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1.
Crit Care ; 25(1): 305, 2021 08 24.
Article in English | MEDLINE | ID: covidwho-1582036

ABSTRACT

BACKGROUND: Awake prone position is an emerging rescue therapy applied in patients undergoing noninvasive ventilation (NIV) for acute hypoxemic respiratory failure (ARF) related to novel coronavirus disease (COVID-19). Although applied to stabilize respiratory status, in awake patients, the application of prone position may reduce comfort with a consequent increase in the workload imposed on respiratory muscles. Thus, we primarily ascertained the effect of awake prone position on diaphragmatic thickening fraction, assessed through ultrasound, in COVID-19 patients undergoing NIV. METHODS: We enrolled all COVID-19 adult critically ill patients, admitted to intensive care unit (ICU) for hypoxemic ARF and undergoing NIV, deserving of awake prone positioning as a rescue therapy. Exclusion criteria were pregnancy and any contraindication to awake prone position and NIV. On ICU admission, after NIV onset, in supine position, and at 1 h following awake prone position application, diaphragmatic thickening fraction was obtained on the right side. Across all the study phases, NIV was maintained with the same setting present at study entry. Vital signs were monitored throughout the entire study period. Comfort was assessed through numerical rating scale (0 the worst comfort and 10 the highest comfort level). Data were presented in median and 25th-75th percentile range. RESULTS: From February to May 2021, 20 patients were enrolled and finally analyzed. Despite peripheral oxygen saturation improvement [96 (94-97)% supine vs 98 (96-99)% prone, p = 0.008], turning to prone position induced a worsening in comfort score from 7.0 (6.0-8.0) to 6.0 (5.0-7.0) (p = 0.012) and an increase in diaphragmatic thickening fraction from 33.3 (25.7-40.5)% to 41.5 (29.8-50.0)% (p = 0.025). CONCLUSIONS: In our COVID-19 patients assisted by NIV in ICU, the application of awake prone position improved the oxygenation at the expense of a greater diaphragmatic thickening fraction compared to supine position. Trial registration ClinicalTrials.gov, number NCT04904731. Registered on 05/25/2021, retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT04904731 .


Subject(s)
COVID-19/therapy , Noninvasive Ventilation/methods , Patient Positioning , Prone Position , Respiration, Artificial/methods , Wakefulness , Adult , Diaphragm , Female , Humans , Intensive Care Units , Male , Pneumonia, Ventilator-Associated/prevention & control , Prospective Studies
2.
Int J Immunopathol Pharmacol ; 35: 20587384211059675, 2021.
Article in English | MEDLINE | ID: covidwho-1582485

ABSTRACT

INTRODUCTION: The fully-human monoclonal anti-interleukin (IL)-1ß antibody canakinumab may inhibit the production of inflammatory mediators in patients with coronavirus disease 2019 (COVID-19) and the hyperinflammatory response potentially leading to acute respiratory distress syndrome. OBJECTIVES: The goal of our retrospective, observational analysis was to evaluate the safety and efficacy of subcutaneous (s.c.) canakinumab in combination with our standard of care (SOC) treatment of selected patients with COVID-19 with respiratory failure and elevated reactive pro-inflammatory markers. METHODS: Eight participants received two doses of s.c. canakinumab 150 mg (or 2 mg/kg for participants weighing ≤40 kg) in addition to SOC. 12 patients received only SOC treatment. RESULTS: Canakinumab treatment reduced the need for mechanical ventilation and reduced proinflammatory markers, resulting in an amelioration of the final outcome, with respect to the control group who received SOC alone. The treatment was safe and well tolerated; no adverse events were reported. CONCLUSION: The use of canakinumab (300 mg, s.c.) in the early stage of COVID-19 with mild-to-moderate respiratory failure was superior to SOC at preventing clinical deterioration and may warrant further investigation as a treatment option for patients with COVID-19 who experience a hyperinflammatory response in the early stage of the disease.


Subject(s)
Antibodies, Monoclonal, Humanized , COVID-19 , Interleukin-1beta , Respiration, Artificial , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal, Humanized/immunology , Biomarkers/blood , COVID-19/complications , COVID-19/epidemiology , COVID-19/immunology , COVID-19/therapy , Dose-Response Relationship, Drug , Female , Humans , Inflammation Mediators/blood , Interleukin-1beta/antagonists & inhibitors , Interleukin-1beta/immunology , Italy/epidemiology , Male , Middle Aged , Monitoring, Immunologic/methods , Outcome and Process Assessment, Health Care , Patient Selection , Respiration, Artificial/methods , Respiration, Artificial/statistics & numerical data , Retrospective Studies , SARS-CoV-2 , Time-to-Treatment
3.
Nutrients ; 14(1)2021 Dec 29.
Article in English | MEDLINE | ID: covidwho-1580548

ABSTRACT

The outbreak of the new coronavirus strain SARS-CoV-2 (COVID-19) highlighted the need for appropriate feeding practices among critically ill patients admitted to the intensive care unit (ICU). This study aimed to describe feeding practices of intubated COVID-19 patients during their second week of hospitalization in the First Department of Critical Care Medicine, Evaggelismos General Hospital, and evaluate potential associations with all cause 30-day mortality, length of hospital stay, and duration of mechanical ventilation. We enrolled adult intubated COVID-19 patients admitted to the ICU between September 2020 and July 2021 and prospectively monitored until their hospital discharge. Of the 162 patients analyzed (52.8% men, 51.6% overweight/obese, mean age 63.2 ± 11.9 years), 27.2% of patients used parenteral nutrition, while the rest were fed enterally. By 30 days, 34.2% of the patients in the parenteral group had died compared to 32.7% of the patients in the enteral group (relative risk (RR) for the group receiving enteral nutrition = 0.97, 95% confidence interval = 0.88-1.06, p = 0.120). Those in the enteral group demonstrated a lower duration of hospital stay (RR = 0.91, 95% CI = 0.85-0.97, p = 0.036) as well as mechanical ventilation support (RR = 0.94, 95% CI = 0.89-0.99, p = 0.043). Enteral feeding during second week of ICU hospitalization may be associated with a shorter duration of hospitalization and stay in mechanical ventilation support among critically ill intubated patients with COVID-19.


Subject(s)
COVID-19/mortality , COVID-19/therapy , Critical Care/methods , Enteral Nutrition/statistics & numerical data , Parenteral Nutrition/statistics & numerical data , Respiration, Artificial/mortality , Critical Illness , Enteral Nutrition/methods , Enteral Nutrition/mortality , Female , Greece/epidemiology , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Parenteral Nutrition/methods , Parenteral Nutrition/mortality , Prospective Studies , Respiration, Artificial/methods , SARS-CoV-2 , Time Factors , Treatment Outcome
4.
J Med Virol ; 93(12): 6737-6749, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1544327

ABSTRACT

Chloroquine or its derivative hydroxychloroquine (HCQ) combined with or without azithromycin (AZ) have been widely investigated in observational studies as a treatment option for coronavirus 2019 (COVID-19) infection. The network meta-analysis aims to summarize evidence from randomized controlled trials (RCTs) to determine if AZ or HCQ is associated with improved clinical outcomes. PubMed and Embase were searched from inception to March 7, 2021. We included published RCTs that investigated the efficacy of AZ, HCQ, or its combination among hospitalized patients with COVID-19 infection. The outcomes of interest were all-cause mortality and the use of mechanical ventilation. The pooled odds ratio was calculated using a random-effect model. A total of 10 RCTs were analyzed. Participant's mean age ranged from 40.4 to 66.5 years. There was no significant effect on mortality associated with AZ plus HCQ (odds ratio [OR] = 0.562 [95% confidence interval {CI}: 0.168-1.887]), AZ alone (OR = 0.965 [95% CI: 0.865-1.077]), or HCQ alone (OR = 1.122 [95% CI: 0.995-1.266]; p = 0.06). Similarly, based on pooled effect sizes derived from direct and indirect evidence, none of the treatments had a significant benefit in decreasing the use of mechanical ventilation. No heterogeneity was identified (Cochran's Q = 1.68; p = 0.95; τ2 = 0; I2 = 0% [95% CI: 0%-0%]). Evidence from RCTs suggests that AZ with or without HCQ was not associated with a significant effect on the mortality or mechanical ventilation rates in hospitalized patients with COVID-19. More research is needed to explore therapeutics agents that can effectively reduce the mortality or severity of COVID-19.


Subject(s)
Antiviral Agents/therapeutic use , Azithromycin/therapeutic use , COVID-19/drug therapy , Hydroxychloroquine/therapeutic use , Adult , Aged , Chloroquine/therapeutic use , Female , Humans , Male , Middle Aged , Network Meta-Analysis , Randomized Controlled Trials as Topic , Respiration, Artificial/methods
5.
Lancet Respir Med ; 9(5): 511-521, 2021 05.
Article in English | MEDLINE | ID: covidwho-1537197

ABSTRACT

BACKGROUND: Global randomised controlled trials of the anti-IL-6 receptor antibody tocilizumab in patients admitted to hospital with COVID-19 have shown conflicting results but potential decreases in time to discharge and burden on intensive care. Tocilizumab reduced progression to mechanical ventilation and death in a trial population enriched for racial and ethnic minorities. We aimed to investigate whether tocilizumab treatment could prevent COVID-19 progression in the first multicentre randomised controlled trial of tocilizumab done entirely in a lower-middle-income country. METHODS: COVINTOC is an open-label, multicentre, randomised, controlled, phase 3 trial done at 12 public and private hospitals across India. Adults (aged ≥18 years) admitted to hospital with moderate to severe COVID-19 (Indian Ministry of Health grading) confirmed by positive SARS-CoV-2 PCR result were randomly assigned (1:1 block randomisation) to receive tocilizumab 6 mg/kg plus standard care (the tocilizumab group) or standard care alone (the standard care group). The primary endpoint was progression of COVID-19 (from moderate to severe or from severe to death) up to day 14 in the modified intention-to-treat population of all participants who had at least one post-baseline assessment for the primary endpoint. Safety was assessed in all randomly assigned patients. The trial is completed and registered with the Clinical Trials Registry India (CTRI/2020/05/025369). FINDINGS: 180 patients were recruited between May 30, 2020, and Aug 31, 2020, and randomly assigned to the tocilizumab group (n=90) or the standard care group (n=90). One patient randomly assigned to the standard care group inadvertently received tocilizumab at baseline and was included in the tocilizumab group for all analyses. One patient randomly assigned to the standard care group withdrew consent after the baseline visit and did not receive any study medication and was not included in the modified intention-to-treat population but was still included in safety analyses. 75 (82%) of 91 in the tocilizumab group and 68 (76%) of 89 in the standard care group completed 28 days of follow-up. Progression of COVID-19 up to day 14 occurred in eight (9%) of 91 patients in the tocilizumab group and 11 (13%) of 88 in the standard care group (difference -3·71 [95% CI -18·23 to 11·19]; p=0·42). 33 (36%) of 91 patients in the tocilizumab group and 22 (25%) of 89 patients in the standard care group had adverse events; 18 (20%) and 15 (17%) had serious adverse events. The most common adverse event was acute respiratory distress syndrome, reported in seven (8%) patients in each group. Grade 3 adverse events were reported in two (2%) patients in the tocilizumab group and five (6%) patients in the standard care group. There were no grade 4 adverse events. Serious adverse events were reported in 18 (20%) patients in the tocilizumab group and 15 (17%) in the standard care group; 13 (14%) and 15 (17%) patients died during the study. INTERPRETATION: Routine use of tocilizumab in patients admitted to hospital with moderate to severe COVID-19 is not supported. However, post-hoc evidence from this study suggests tocilizumab might still be effective in patients with severe COVID-19 and so should be investigated further in future studies. FUNDING: Medanta Institute of Education and Research, Roche India, Cipla India, and Action COVID-19 India.


Subject(s)
Antibodies, Monoclonal, Humanized , COVID-19 , Cytokine Release Syndrome , Receptors, Interleukin-6/antagonists & inhibitors , Respiratory Distress Syndrome , SARS-CoV-2/isolation & purification , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , COVID-19/complications , COVID-19/immunology , COVID-19/mortality , COVID-19/therapy , Critical Care/methods , Cytokine Release Syndrome/drug therapy , Cytokine Release Syndrome/etiology , Cytokine Release Syndrome/immunology , Drug Monitoring/methods , Female , Humans , Immunologic Factors/administration & dosage , Immunologic Factors/adverse effects , India , Male , Middle Aged , Mortality , Respiration, Artificial/methods , Respiratory Distress Syndrome/diagnosis , Respiratory Distress Syndrome/etiology , Severity of Illness Index , Treatment Outcome
6.
Lancet Respir Med ; 9(5): 487-497, 2021 05.
Article in English | MEDLINE | ID: covidwho-1537196

ABSTRACT

BACKGROUND: Lung transplantation is a life-saving treatment for patients with end-stage lung disease; however, it is infrequently considered for patients with acute respiratory distress syndrome (ARDS) attributable to infectious causes. We aimed to describe the course of disease and early post-transplantation outcomes in critically ill patients with COVID-19 who failed to show lung recovery despite optimal medical management and were deemed to be at imminent risk of dying due to pulmonary complications. METHODS: We established a multi-institutional case series that included the first consecutive transplants for severe COVID-19-associated ARDS known to us in the USA, Italy, Austria, and India. De-identified data from participating centres-including information relating to patient demographics and pre-COVID-19 characteristics, pretransplantation disease course, perioperative challenges, pathology of explanted lungs, and post-transplantation outcomes-were collected by Northwestern University (Chicago, IL, USA) and analysed. FINDINGS: Between May 1 and Sept 30, 2020, 12 patients with COVID-19-associated ARDS underwent bilateral lung transplantation at six high-volume transplant centres in the USA (eight recipients at three centres), Italy (two recipients at one centre), Austria (one recipient), and India (one recipient). The median age of recipients was 48 years (IQR 41-51); three of the 12 patients were female. Chest imaging before transplantation showed severe lung damage that did not improve despite prolonged mechanical ventilation and extracorporeal membrane oxygenation. The lung transplant procedure was technically challenging, with severe pleural adhesions, hilar lymphadenopathy, and increased intraoperative transfusion requirements. Pathology of the explanted lungs showed extensive, ongoing acute lung injury with features of lung fibrosis. There was no recurrence of SARS-CoV-2 in the allografts. All patients with COVID-19 could be weaned off extracorporeal support and showed short-term survival similar to that of transplant recipients without COVID-19. INTERPRETATION: The findings from our report show that lung transplantation is the only option for survival in some patients with severe, unresolving COVID-19-associated ARDS, and that the procedure can be done successfully, with good early post-transplantation outcomes, in carefully selected patients. FUNDING: National Institutes of Health. VIDEO ABSTRACT.


Subject(s)
COVID-19 , Critical Illness/therapy , Lung Transplantation/methods , Lung , Respiratory Distress Syndrome , Blood Transfusion/methods , COVID-19/complications , COVID-19/diagnosis , COVID-19/physiopathology , COVID-19/surgery , Critical Care/methods , Extracorporeal Membrane Oxygenation/methods , Female , Humans , Intraoperative Care/methods , Lung/diagnostic imaging , Lung/pathology , Male , Middle Aged , Outcome and Process Assessment, Health Care , Pulmonary Fibrosis/etiology , Pulmonary Fibrosis/pathology , Respiration, Artificial/methods , Respiratory Distress Syndrome/etiology , Respiratory Distress Syndrome/surgery , SARS-CoV-2/pathogenicity
7.
BMC Cardiovasc Disord ; 21(1): 528, 2021 11 08.
Article in English | MEDLINE | ID: covidwho-1505900

ABSTRACT

BACKGROUND: The value of mechanical circulatory support (MCS) in cardiogenic shock, especially the combination of the ECMELLA approach (Impella combined with ECMO), remains controversial. CASE PRESENTATION: A previously healthy 33-year-old female patient was submitted to a local emergency department with a flu-like infection and febrile temperatures up to 39 °C. The patient was tested positive for type-A influenza, however negative for SARS-CoV-2. Despite escalated invasive ventilation, refractory hypercapnia (paCO2: 22 kPa) with severe respiratory acidosis (pH: 6.9) and a rising norepinephrine rate occurred within a few hours. Due to a Horovitz-Index < 100, out-of-centre veno-venous extracorporeal membrane oxygenation (vv-ECMO)-implantation was performed. A CT-scan done because of anisocoria revealed an extended dissection of the right vertebral artery. While the initial left ventricular function was normal, echocardiography revealed severe global hypokinesia. After angiographic exclusion of coronary artery stenoses, we geared up LV unloading by additional implantation of an Impella CP and expanded the vv-ECMO to a veno-venous-arterial ECMO (vva-ECMO). Clinically relevant bleeding from the punctured femoral arteries resulted in massive transfusion and was treated by vascular surgery later on. Under continued MCS, LVEF increased to approximately 40% 2 days after the initiation of ECMELLA. After weaning, the Impella CP was explanted at day 5 and the vva-ECMO was removed on day 9, respectively. The patient was discharged in an unaffected neurological condition to rehabilitation 25 days after the initial admission. CONCLUSIONS: This exceptional case exemplifies the importance of aggressive MCS in severe cardiogenic shock, which may be especially promising in younger patients with non-ischaemic cardiomyopathy and potentially reversible causes of cardiogenic shock. This case impressively demonstrates that especially young patients may achieve complete neurological restoration, even though the initial prognosis may appear unfavourable.


Subject(s)
Extracorporeal Membrane Oxygenation/methods , Heart-Assist Devices , Influenza A virus/isolation & purification , Influenza, Human , Respiration, Artificial/methods , Respiratory Insufficiency , Ventricular Dysfunction, Left , Adult , COVID-19/diagnosis , Clinical Deterioration , Critical Care/methods , Echocardiography/methods , Female , Heart Failure/physiopathology , Heart Failure/therapy , Humans , Influenza, Human/complications , Influenza, Human/diagnosis , Influenza, Human/physiopathology , Respiratory Insufficiency/etiology , Respiratory Insufficiency/physiopathology , Respiratory Insufficiency/therapy , SARS-CoV-2 , Serologic Tests/methods , Severity of Illness Index , Shock, Cardiogenic/etiology , Shock, Cardiogenic/physiopathology , Shock, Cardiogenic/therapy , Treatment Outcome , Ventricular Dysfunction, Left/etiology , Ventricular Dysfunction, Left/physiopathology , Ventricular Dysfunction, Left/therapy
8.
PLoS One ; 16(11): e0259658, 2021.
Article in English | MEDLINE | ID: covidwho-1503743

ABSTRACT

OBJECTIVES: To investigate nurses' behavioral intention toward caring for COVID-19 patients on mechanical ventilation, as well as the factors affecting their intention. BACKGROUND: COVID-19 patients undergoing mechanical ventilation have many care needs and pose more challenges for nurses, which might adversely affect nurses' intention toward caring behavior. METHODS: A cross-sectional study was conducted by using simple random sampling to recruit 598 nurses from five tertiary hospitals in Sichuan Province, China. The participants responded to an online questionnaire that included questions on demographic characteristics; the Attitude, Subjective Norms, and Behavioral Intention of Nurses toward Mechanically Ventilated Patients (ASIMP) questionnaire; the Nursing Professional Identity Scale (NPIS); and the Compassion Fatigue-Short Scale (CF-Short Scale). ANOVA, Spearman correlation analysis, and multiple linear regression were performed to analyze the data. RESULTS: The mean total behavioral intention score was 179.46 (± 14.83) out of a total score of 189.00, which represented a high level of intention toward caring for patients on mechanical ventilation. Multiple linear regression revealed that subjective norms (ß = 0.390, P<0.001), perceived behavioral control (ß = 0.149, P<0.001), professional identity (ß = 0.101, P = 0.009), and compassion fatigue (ß = 0.088 P = 0.024) were significant predictors of nurses' behavioral intention. CONCLUSIONS: Most nurses have a positive behavioral intention to care for COVID-19 patients undergoing mechanical ventilation. The findings in this study provide some insight for developing effective and tailored strategies to promote nurses' behavioral intention toward caring for ventilated patients under the pandemic situation.


Subject(s)
Attitude of Health Personnel , COVID-19/therapy , Nurses , Respiration, Artificial/methods , Adult , Behavior , China/epidemiology , Compassion Fatigue , Cross-Sectional Studies , Female , Humans , Job Satisfaction , Male , Nursing Staff, Hospital , Pandemics , Regression Analysis , Surveys and Questionnaires , Young Adult
10.
Eur Respir Rev ; 30(162)2021 Dec 31.
Article in English | MEDLINE | ID: covidwho-1477254

ABSTRACT

Coronavirus disease 2019 (COVID-19) pneumonia is an evolving disease. We will focus on the development of its pathophysiologic characteristics over time, and how these time-related changes determine modifications in treatment. In the emergency department: the peculiar characteristic is the coexistence, in a significant fraction of patients, of severe hypoxaemia, near-normal lung computed tomography imaging, lung gas volume and respiratory mechanics. Despite high respiratory drive, dyspnoea and respiratory rate are often normal. The underlying mechanism is primarily altered lung perfusion. The anatomical prerequisites for PEEP (positive end-expiratory pressure) to work (lung oedema, atelectasis, and therefore recruitability) are lacking. In the high-dependency unit: the disease starts to worsen either because of its natural evolution or additional patient self-inflicted lung injury (P-SILI). Oedema and atelectasis may develop, increasing recruitability. Noninvasive supports are indicated if they result in a reversal of hypoxaemia and a decreased inspiratory effort. Otherwise, mechanical ventilation should be considered to avert P-SILI. In the intensive care unit: the primary characteristic of the advance of unresolved COVID-19 disease is a progressive shift from oedema or atelectasis to less reversible structural lung alterations to lung fibrosis. These later characteristics are associated with notable impairment of respiratory mechanics, increased arterial carbon dioxide tension (P aCO2 ), decreased recruitability and lack of response to PEEP and prone positioning.


Subject(s)
COVID-19/physiopathology , COVID-19/therapy , Lung/physiopathology , Positive-Pressure Respiration/methods , Respiration, Artificial/methods , Humans , Pulmonary Atelectasis/prevention & control , Respiratory Mechanics , SARS-CoV-2
12.
Ann Surg ; 274(5): e388-e394, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1455430

ABSTRACT

OBJECTIVE: Does extracorporeal membrane oxygenation (ECMO) improve outcomes in ECMO-eligible patients with COVID-19 respiratory failure compared to maximum ventilation alone (MVA)? SUMMARY BACKGROUND DATA: ECMO is beneficial in severe cases of respiratory failure when mechanical ventilation is inadequate. Outcomes for ECMO-eligible COVID-19 patients on MVA have not been reported. Consequently, a direct comparison between COVID-19 patients on ECMO and those on MVA has not been established. METHODS: A total of 3406 COVID-19 patients treated at two major medical centers in Chicago were studied. One hundred ninety-five required maximum ventilatory support, and met ECMO eligibility criteria. Eighty ECMO patients were propensity matched to an equal number of MVA patients using detailed demographic, physiological, and comorbidity data. Primary outcome was survival and disposition at discharge. RESULTS: Seventy-one percent of patients were decannulated from ECMO. Mechanical ventilation was discontinued in 75% ECMO and 16% MVA patients. Twenty-five percent of patients in the ECMO arm expired, 21% while on ECMO, compared with 74% in the MVA cohort. Mortality was significantly lower across all age and BMI groups in the ECMO arm. Sixty-eight percent ECMO and 26% MVA patients were discharged from the hospital. Fewer ECMO patients required long-term rehabilitation. Major complications such as septic shock, ventilator associated pneumonia, inotropic requirements, acute liver and kidney injuries are less frequent among ECMO patients. CONCLUSIONS: ECMO-eligible patients with severe COVID-19 respiratory failure demonstrate a 3-fold improvement in survival with ECMO. They are also in a better physical state at discharge and have lower overall complication rates. As such, strong consideration should be given for ECMO when mechanical ventilatory support alone becomes insufficient in treating COVID-19 respiratory failure.


Subject(s)
COVID-19/therapy , Extracorporeal Membrane Oxygenation/methods , Propensity Score , Respiration, Artificial/methods , Respiratory Insufficiency/therapy , Adult , Aged , COVID-19/complications , COVID-19/epidemiology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pandemics , Patient Discharge/trends , Respiratory Insufficiency/epidemiology , Respiratory Insufficiency/etiology , Retrospective Studies , SARS-CoV-2 , Severity of Illness Index , Survival Rate/trends , United States/epidemiology , Young Adult
13.
Crit Care Med ; 49(10): 1684-1693, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1452742

ABSTRACT

OBJECTIVES: Clinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators. DESIGN: A 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process. PARTICIPANTS: Thirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process. MEASUREMENTS AND MAIN RESULTS: The final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization. CONCLUSIONS: These recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.


Subject(s)
Hypnotics and Sedatives/pharmacokinetics , Hypnotics and Sedatives/therapeutic use , Congresses as Topic , Consensus , Delphi Technique , District of Columbia , Humans , Hypnotics and Sedatives/pharmacology , Respiration, Artificial/instrumentation , Respiration, Artificial/methods , Time Factors
14.
Eur Rev Med Pharmacol Sci ; 25(18): 5853-5856, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1451043

ABSTRACT

Coronavirus disease 2019-induced acute respiratory distress syndrome (ARDS) is more severe in morbidly obese patients. Mechanical ventilation differs between obese and non-obese patients. We examined these differences in an obese (body mass index = 47 kg/m2) 32-year-old patient followed up in our clinic. The patient was admitted to the intensive care unit due to respiratory failure. Recruitment maneuvers were performed in pressure-controlled ventilation mode. The optimal positive end-expiratory pressure was 25 cm H2O. The inspiratory pressure was adjusted to 45 cm H2O to provide a tidal volume of 6 ml/kg and driving pressure ≤ 15. The patient was discharged with full recovery.


Subject(s)
COVID-19/therapy , Obesity, Morbid , Respiration, Artificial/methods , Respiratory Distress Syndrome/therapy , Adult , COVID-19/blood , COVID-19/complications , COVID-19/diagnostic imaging , Humans , Intensive Care Units , Male , Obesity, Morbid/complications , Positive-Pressure Respiration/methods , Respiratory Distress Syndrome/complications , Tidal Volume
15.
Eur J Med Res ; 26(1): 117, 2021 Oct 02.
Article in English | MEDLINE | ID: covidwho-1448444

ABSTRACT

BACKGROUND: Interleukin-6 receptor antagonists (IL-6RAs) and steroids are emerging immunomodulatory therapies for severe and critical coronavirus disease (COVID-19). In this preliminary report, we aim to describe the epidemiology, clinical characteristics, and outcomes of adult critically ill COVID-19 patients, requiring invasive mechanical ventilation (iMV), and receiving IL-6RA and steroids therapy over the last 11 months. MATERIALS AND METHODS: International, multicenter, cohort study derived from Viral Infection and Respiratory Illness University Study registry and conducted through Discovery Network, Society of Critical Care Medicine. Data were collected between March 01, 2020, and January 10, 2021. RESULTS: Of 860 patients who met eligibility criteria, 589 received steroids, 170 IL-6RAs, and 101 combinations. Patients who received IL-6RAs were younger (median age of 57.5 years vs. 61.1 and 61.8 years in the steroids and combination groups, respectively). The median C-reactive protein level was > 75 mg/L, indicating a hyperinflammatory phenotype. The median daily steroid dose was 7.5 mg dexamethasone or equivalent (interquartile range: 6-14 mg); 80.8% and 19.2% received low-dose and high-dose steroids, respectively. Of the patients who received IL-6RAs, the majority received one dose of tocilizumab and sarilumab (dose range of 600-800 mg for tocilizumab and 200-400 mg for sarilumab). Regarding the timing of administration, we observed that steroid and IL-6RA administration on day 0 of ICU admission was only 55.6% and 39.5%, respectively. By day 28, when compared with steroid use alone, IL-6RA use was associated with an adjusted incidence rate ratio (aIRR) of 1.12 (95% confidence interval [CI] 0.88, 1.4) for ventilator-free days, while combination therapy was associated with an aIRR of 0.83 (95% CI 0.6, 1.14). IL-6RA use was associated with an adjusted odds ratio (aOR) of 0.68 (95% CI 0.44, 1.07) for the 28-day mortality rate, while combination therapy was associated with an aOR of 1.07 (95% CI 0.67, 1.70). Liver dysfunction was higher in IL-6RA group (p = 0.04), while the bacteremia rate did not differ among groups. CONCLUSIONS: Discordance was observed between the registry utilization patterns (i.e., timing of steroids and IL-6RA administration) and new evidence from the recent randomized controlled trials and guideline recommendations. These data will help us to identify areas of improvement in prescribing patterns and enhance our understanding of IL-6RA safety with different steroid regimens. Further studies are needed to evaluate the drivers of hospital-level variation and their impact on clinical outcomes. Trial registration ClinicalTrials.gov: NCT04486521. Registered on July 2020.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , COVID-19/complications , Receptors, Interleukin-6/antagonists & inhibitors , Registries/statistics & numerical data , Respiration, Artificial/methods , Respiratory Insufficiency/mortality , SARS-CoV-2/isolation & purification , Adolescent , Adult , Aged , Aged, 80 and over , Critical Illness , Female , Follow-Up Studies , Humans , International Agencies , Male , Middle Aged , Prognosis , Respiratory Insufficiency/epidemiology , Respiratory Insufficiency/therapy , Respiratory Insufficiency/virology , Survival Rate , Young Adult
16.
ASAIO J ; 67(10): 1097-1099, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1443141

ABSTRACT

COVID-19 can be associated with acute respiratory distress syndrome, which increases the likelihood of morbidity and mortality. Ventilator-induced lung injury is a known complication of mechanical ventilation (MV) and can further compound lung injury and recovery. Escalation to extracorporeal membrane oxygenation can be required in patients who deteriorate on MV. We report our experience with complete avoidance of MV using an ECMO First strategy deployed in an awake nonintubated COVID-19 patient with severe pneumonia.


Subject(s)
COVID-19/therapy , Extracorporeal Membrane Oxygenation/methods , Lung Injury/therapy , Respiratory Distress Syndrome/therapy , Extracorporeal Membrane Oxygenation/adverse effects , Humans , Respiration, Artificial/adverse effects , Respiration, Artificial/methods , SARS-CoV-2 , Ventilator-Induced Lung Injury/etiology , Ventilator-Induced Lung Injury/prevention & control
17.
JAMA ; 326(11): 1013-1023, 2021 09 21.
Article in English | MEDLINE | ID: covidwho-1441906

ABSTRACT

Importance: In patients who require mechanical ventilation for acute hypoxemic respiratory failure, further reduction in tidal volumes, compared with conventional low tidal volume ventilation, may improve outcomes. Objective: To determine whether lower tidal volume mechanical ventilation using extracorporeal carbon dioxide removal improves outcomes in patients with acute hypoxemic respiratory failure. Design, Setting, and Participants: This multicenter, randomized, allocation-concealed, open-label, pragmatic clinical trial enrolled 412 adult patients receiving mechanical ventilation for acute hypoxemic respiratory failure, of a planned sample size of 1120, between May 2016 and December 2019 from 51 intensive care units in the UK. Follow-up ended on March 11, 2020. Interventions: Participants were randomized to receive lower tidal volume ventilation facilitated by extracorporeal carbon dioxide removal for at least 48 hours (n = 202) or standard care with conventional low tidal volume ventilation (n = 210). Main Outcomes and Measures: The primary outcome was all-cause mortality 90 days after randomization. Prespecified secondary outcomes included ventilator-free days at day 28 and adverse event rates. Results: Among 412 patients who were randomized (mean age, 59 years; 143 [35%] women), 405 (98%) completed the trial. The trial was stopped early because of futility and feasibility following recommendations from the data monitoring and ethics committee. The 90-day mortality rate was 41.5% in the lower tidal volume ventilation with extracorporeal carbon dioxide removal group vs 39.5% in the standard care group (risk ratio, 1.05 [95% CI, 0.83-1.33]; difference, 2.0% [95% CI, -7.6% to 11.5%]; P = .68). There were significantly fewer mean ventilator-free days in the extracorporeal carbon dioxide removal group compared with the standard care group (7.1 [95% CI, 5.9-8.3] vs 9.2 [95% CI, 7.9-10.4] days; mean difference, -2.1 [95% CI, -3.8 to -0.3]; P = .02). Serious adverse events were reported for 62 patients (31%) in the extracorporeal carbon dioxide removal group and 18 (9%) in the standard care group, including intracranial hemorrhage in 9 patients (4.5%) vs 0 (0%) and bleeding at other sites in 6 (3.0%) vs 1 (0.5%) in the extracorporeal carbon dioxide removal group vs the control group. Overall, 21 patients experienced 22 serious adverse events related to the study device. Conclusions and Relevance: Among patients with acute hypoxemic respiratory failure, the use of extracorporeal carbon dioxide removal to facilitate lower tidal volume mechanical ventilation, compared with conventional low tidal volume mechanical ventilation, did not significantly reduce 90-day mortality. However, due to early termination, the study may have been underpowered to detect a clinically important difference. Trial Registration: ClinicalTrials.gov Identifier: NCT02654327.


Subject(s)
Carbon Dioxide/blood , Extracorporeal Circulation , Respiration, Artificial/methods , Respiratory Insufficiency/therapy , Aged , Early Termination of Clinical Trials , Extracorporeal Circulation/adverse effects , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Respiration, Artificial/adverse effects , Respiratory Distress Syndrome/therapy , Respiratory Insufficiency/mortality , Tidal Volume
18.
Crit Care ; 25(1): 214, 2021 06 21.
Article in English | MEDLINE | ID: covidwho-1440944

ABSTRACT

BACKGROUND: Critically ill COVID-19 patients have pathophysiological lung features characterized by perfusion abnormalities. However, to date no study has evaluated whether the changes in the distribution of pulmonary gas and blood volume are associated with the severity of gas-exchange impairment and the type of respiratory support (non-invasive versus invasive) in patients with severe COVID-19 pneumonia. METHODS: This was a single-center, retrospective cohort study conducted in a tertiary care hospital in Northern Italy during the first pandemic wave. Pulmonary gas and blood distribution was assessed using a technique for quantitative analysis of dual-energy computed tomography. Lung aeration loss (reflected by percentage of normally aerated lung tissue) and the extent of gas:blood volume mismatch (percentage of non-aerated, perfused lung tissue-shunt; aerated, non-perfused dead space; and non-aerated/non-perfused regions) were evaluated in critically ill COVID-19 patients with different clinical severity as reflected by the need for non-invasive or invasive respiratory support. RESULTS: Thirty-five patients admitted to the intensive care unit between February 29th and May 30th, 2020 were included. Patients requiring invasive versus non-invasive mechanical ventilation had both a lower percentage of normally aerated lung tissue (median [interquartile range] 33% [24-49%] vs. 63% [44-68%], p < 0.001); and a larger extent of gas:blood volume mismatch (43% [30-49%] vs. 25% [14-28%], p = 0.001), due to higher shunt (23% [15-32%] vs. 5% [2-16%], p = 0.001) and non-aerated/non perfused regions (5% [3-10%] vs. 1% [0-2%], p = 0.001). The PaO2/FiO2 ratio correlated positively with normally aerated tissue (ρ = 0.730, p < 0.001) and negatively with the extent of gas-blood volume mismatch (ρ = - 0.633, p < 0.001). CONCLUSIONS: In critically ill patients with severe COVID-19 pneumonia, the need for invasive mechanical ventilation and oxygenation impairment were associated with loss of aeration and the extent of gas:blood volume mismatch.


Subject(s)
Blood Volume/physiology , COVID-19/diagnostic imaging , COVID-19/metabolism , Lung/diagnostic imaging , Lung/metabolism , Pulmonary Gas Exchange/physiology , Aged , Blood Gas Analysis/methods , COVID-19/epidemiology , Cohort Studies , Critical Illness/epidemiology , Female , Humans , Italy/epidemiology , Male , Middle Aged , Respiration, Artificial/methods , Retrospective Studies , Tomography, X-Ray Computed/methods
19.
Crit Care ; 25(1): 331, 2021 09 13.
Article in English | MEDLINE | ID: covidwho-1413915

ABSTRACT

BACKGROUND: Mortality due to COVID-19 is high, especially in patients requiring mechanical ventilation. The purpose of the study is to investigate associations between mortality and variables measured during the first three days of mechanical ventilation in patients with COVID-19 intubated at ICU admission. METHODS: Multicenter, observational, cohort study includes consecutive patients with COVID-19 admitted to 44 Spanish ICUs between February 25 and July 31, 2020, who required intubation at ICU admission and mechanical ventilation for more than three days. We collected demographic and clinical data prior to admission; information about clinical evolution at days 1 and 3 of mechanical ventilation; and outcomes. RESULTS: Of the 2,095 patients with COVID-19 admitted to the ICU, 1,118 (53.3%) were intubated at day 1 and remained under mechanical ventilation at day three. From days 1 to 3, PaO2/FiO2 increased from 115.6 [80.0-171.2] to 180.0 [135.4-227.9] mmHg and the ventilatory ratio from 1.73 [1.33-2.25] to 1.96 [1.61-2.40]. In-hospital mortality was 38.7%. A higher increase between ICU admission and day 3 in the ventilatory ratio (OR 1.04 [CI 1.01-1.07], p = 0.030) and creatinine levels (OR 1.05 [CI 1.01-1.09], p = 0.005) and a lower increase in platelet counts (OR 0.96 [CI 0.93-1.00], p = 0.037) were independently associated with a higher risk of death. No association between mortality and the PaO2/FiO2 variation was observed (OR 0.99 [CI 0.95 to 1.02], p = 0.47). CONCLUSIONS: Higher ventilatory ratio and its increase at day 3 is associated with mortality in patients with COVID-19 receiving mechanical ventilation at ICU admission. No association was found in the PaO2/FiO2 variation.


Subject(s)
COVID-19/therapy , Respiration, Artificial/methods , Respiratory Distress Syndrome/therapy , Ventilation-Perfusion Ratio/physiology , Aged , Aged, 80 and over , COVID-19/epidemiology , COVID-19/physiopathology , Cohort Studies , Critical Care/methods , Critical Care/trends , Female , Hospital Mortality/trends , Humans , Intensive Care Units/trends , Male , Middle Aged , Prognosis , Prospective Studies , Pulmonary Ventilation/physiology , Respiration, Artificial/trends , Respiratory Distress Syndrome/epidemiology , Respiratory Distress Syndrome/physiopathology , Retrospective Studies , Spain/epidemiology
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