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1.
IDCases ; 2022.
Article in English | EuropePMC | ID: covidwho-1940008

ABSTRACT

Remdesivir is a direct-acting inhibitor of SARS-CoV-2 RNA-dependent RNA polymerase that is used to treat severe COVID-19 infections. We report a patient with severe COVID-19 pneumonia who have had palpitations and syncope two days after starting remdesivir therapy. The QT interval was prolonged on the Electrocardiogram, but there were no significant electrolyte abnormalities. After completing the remdesivir regimen, the QT interval was normalized. Although the cardiac side effects of remdesivir therapy have been well documented, the link between remdesivir therapy and QT interval prolongation in patients with severe COVID-19 has only been observed in a few cases. Physicians should be aware of QTc interval prolongation associated with remdesivir treatment because this arrhythmia has the potential to cause sudden cardiac death.

2.
IDCases ; 29: e01572, 2022.
Article in English | MEDLINE | ID: covidwho-1935401

ABSTRACT

Remdesivir is a direct-acting inhibitor of SARS-CoV-2 RNA-dependent RNA polymerase that is used to treat severe COVID-19 infections. We report a patient with severe COVID-19 pneumonia who experienced palpitations and syncope two days after starting remdesivir therapy. The QTc interval was prolonged on the Electrocardiogram (ECG) without any significant electrolyte abnormalities or concomitant use of medications with QTc prolongation. Although the cardiac side effects of remdesivir therapy have been well documented, the link between remdesivir therapy and QTc interval prolongation in patients with severe COVID-19 has only been observed in a few cases. Because this arrhythmia has the potential to result in sudden cardiac death, practitioners should be aware of the QTc interval prolongation associated with remdesivir therapy.

3.
Crit Care Clin ; 38(3): 601-621, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1850766

ABSTRACT

High-flow nasal oxygen (HFNO) and noninvasive ventilation (NIV) via facemask or helmet have been increasingly used in managing acute hypoxemic respiratory failure (AHRF) owing to COVID-19 with the premise of reducing the need for invasive mechanical ventilation and possibly mortality. Their use carries the risk of delaying intubation and nosocomial infection transmission. To date, most studies on the effectiveness of these modalities are observational and suggest that HFNO and NIV have a role in the management of AHRF owing to COVID-19. Trials are ongoing and are evaluating different aspects of noninvasive respiratory support in patients with AHRF owing to COVID-19.


Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Insufficiency , COVID-19/therapy , Humans , Oxygen/therapeutic use , Oxygen Inhalation Therapy , Respiration, Artificial , Respiratory Insufficiency/therapy
4.
Trials ; 23(1): 105, 2022 Feb 02.
Article in English | MEDLINE | ID: covidwho-1666670

ABSTRACT

BACKGROUND: Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation has multiple advantages over other oxygen support modalities but data about effectiveness are limited. METHODS: In this multicenter randomized trial of helmet noninvasive ventilation for COVID-19 patients, 320 adult ICU patients (aged ≥14 years or as per local standards) with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (ratio of arterial oxygen partial pressure to fraction of inspired oxygen < 200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate of 10 L/min or higher) will be randomized to helmet noninvasive ventilation with usual care or usual care alone, which may include mask noninvasive ventilation, high-flow nasal oxygen, or standard oxygen therapy. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction in 28-day mortality from 40 to 25%. The primary outcome will be compared between the helmet and usual care group in the intention-to-treat using the chi-square test. Results will be reported as relative risk  and 95% confidence interval. The first patient was enrolled on February 8, 2021. As of August 1, 2021, 252 patients have been enrolled from 7 centers in Saudi Arabia and Kuwait. DISCUSSION: We developed a detailed statistical analysis plan to guide the analysis of the Helmet-COVID trial, which is expected to conclude enrollment in November 2021. TRIAL REGISTRATION: ClinicalTrials.gov NCT04477668 . Registered on July 20, 2020.


Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Insufficiency , Adult , Head Protective Devices , Humans , Noninvasive Ventilation/adverse effects , Respiratory Insufficiency/diagnosis , Respiratory Insufficiency/therapy , SARS-CoV-2
5.
Critical care clinics ; 2022.
Article in English | EuropePMC | ID: covidwho-1615015

ABSTRACT

High-flow nasal oxygen (HFNO) and non-invasive ventilation (NIV) via face-mask or helmet have been increasingly used in the management of acute hypoxemic respiratory failure (AHRF) due to COVID-19 with the premise of reducing the need for invasive mechanical ventilation and possibly mortality. However, their use carries the risk of delaying intubation and nosocomial infection transmission. To this date, most studies on the effectiveness of these modalities are observational and suggest that HFNO and NIV have a role in the management of AHRF due to COVID-19. A randomized controlled trial among patients with COVID-19 showed that helmet NIV versus HFNO led to a lower intubation rate but no difference in survival or the duration of respiratory support. The RECOVERY respiratory support trial demonstrated that CPAP, but not HFNO reduced a composite outcome of tracheal intubation or mortality within 30-days compared with conventional oxygen therapy. Additional trials are ongoing and are evaluating different aspects of noninvasive respiratory support in patients with AHRF due to COVID-19.

6.
Trials ; 22(1): 828, 2021 Nov 22.
Article in English | MEDLINE | ID: covidwho-1528691

ABSTRACT

BACKGROUND: It is unclear whether screening for sepsis using an electronic alert in hospitalized ward patients improves outcomes. The objective of the Stepped-wedge Cluster Randomized Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN) trial is to evaluate whether an electronic screening for sepsis compared to no screening among hospitalized ward patients reduces all-cause 90-day in-hospital mortality. METHODS AND DESIGN: This study is designed as a stepped-wedge cluster randomized trial in which the unit of randomization or cluster is the hospital ward. An electronic alert for sepsis was developed in the electronic medical record (EMR), with the feature of being active (visible to treating team) or masked (inactive in EMR frontend for the treating team but active in the backend of the EMR). Forty-five clusters in 5 hospitals are randomized into 9 sequences of 5 clusters each to receive the intervention (active alert) over 10 periods, 2 months each, the first being the baseline period. Data are extracted from EMR and are compared between the intervention (active alert) and control group (masked alert). During the study period, some of the hospital wards were allocated to manage patients with COVID-19. The primary outcome of all-cause hospital mortality by day 90 will be compared using a generalized linear mixed model with a binary distribution and a log-link function to estimate the relative risk as a measure of effect. We will include two levels of random effects to account for nested clustering within wards and periods and two levels of fixed effects: hospitals and COVID-19 ward status in addition to the intervention. Results will be expressed as relative risk with a 95% confidence interval. CONCLUSION: The SCREEN trial provides an opportunity for a novel trial design and analysis of routinely collected and entered data to evaluate the effectiveness of an intervention (alert) for a common medical problem (sepsis in ward patients). In this statistical analysis plan, we outline details of the planned analyses in advance of trial completion. Prior specification of the statistical methods and outcome analysis will facilitate unbiased analyses of these important clinical data. TRIAL REGISTRATION: ClinicalTrials.gov NCT04078594 . Registered on September 6, 2019.


Subject(s)
COVID-19 , Sepsis , Electronics , Hospitals , Humans , SARS-CoV-2 , Sepsis/diagnosis , Sepsis/therapy
7.
J Infect Public Health ; 14(11): 1635-1641, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1446868

ABSTRACT

BACKGROUND: The COVID-19 pandemic has strained ICUs worldwide. To learn from our experience, we described the critical care response to the outbreak. METHODS: This is a case study of the response of the Intensive Care Department (75-bed capacity) at a tertiary-care hospital to COVID-19 pandemic, which resulted in a high number of critically ill patients. RESULTS: Between March 1 and July 31, 2020, 822 patients were admitted to the adult non-cardiac ICUs with suspected (72%)/confirmed (38%) COVID-19. At the peak of the surge, 125 critically ill patients with COVID-19 were managed on single day. To accommodate these numbers, the bed capacity of 4 ICUs was increased internally from 58 to 71 beds (+40%) by cohorting 2 patients/room in selected rooms; forty additional ICUs beds were created in 2 general wards; one cardiac ICU was converted to managed non-COVID-19 general ICU patients and one ward was used as a stepdown for COVID-19 patients. To manage respiratory failure, 53 new ICU ventilators, 90 helmets for non-invasive ventilation and 47 high-flow nasal cannula machines were added to the existing capacity. Dedicated medical teams cared for the COVID-19 patients to prevent cross-contamination. The nurse-to-patient and RT-to-patient ratio remained mostly 1:1 and 1:6, respectively. One-hundred-ten ward nurses were up-skilled to care for COVID-19 and other ICU patients using tiered staffing model. Daily executive rounds were conducted to identify patients for transfer and at least 10 beds were made available for new COVID-19 admissions/day. The consumption of PPE increased multiple fold compared with the period preceding the pandemic. Regular family visits were not allowed and families were updated daily by videoconferencing and phone calls. CONCLUSIONS: Our ICU response to the COVID-19 pandemic required almost doubling ICU bed capacity and changing multiple aspects of ICU workflow to be able to care for high numbers of affected patients.


Subject(s)
COVID-19 , Pandemics , Adult , Critical Care , Humans , Intensive Care Units , SARS-CoV-2 , Tertiary Care Centers
8.
BMJ Open ; 11(8): e052169, 2021 08 26.
Article in English | MEDLINE | ID: covidwho-1376510

ABSTRACT

INTRODUCTION: Non-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality. METHODS AND ANALYSIS: This is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness. ETHICS AND DISSEMINATION: Approvals are obtained from the institutional review boards of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings. TRIAL REGISTRATION NUMBER: NCT04477668.


Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Insufficiency , Head Protective Devices , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Respiratory Insufficiency/therapy , SARS-CoV-2
9.
Intensive Care Med ; 47(3): 282-291, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1092644

ABSTRACT

Coronavirus disease 19 (COVID-19) has posed unprecedented healthcare system challenges, some of which will lead to transformative change. It is obvious to healthcare workers and policymakers alike that an effective critical care surge response must be nested within the overall care delivery model. The COVID-19 pandemic has highlighted key elements of emergency preparedness. These include having national or regional strategic reserves of personal protective equipment, intensive care unit (ICU) devices, consumables and pharmaceuticals, as well as effective supply chains and efficient utilization protocols. ICUs must also be prepared to accommodate surges of patients and ICU staffing models should allow for fluctuations in demand. Pre-existing ICU triage and end-of-life care principles should be established, implemented and updated. Daily workflow processes should be restructured to include remote connection with multidisciplinary healthcare workers and frequent communication with relatives. The pandemic has also demonstrated the benefits of digital transformation and the value of remote monitoring technologies, such as wireless monitoring. Finally, the pandemic has highlighted the value of pre-existing epidemiological registries and agile randomized controlled platform trials in generating fast, reliable data. The COVID-19 pandemic is a reminder that besides our duty to care, we are committed to improve. By meeting these challenges today, we will be able to provide better care to future patients.


Subject(s)
COVID-19 , Critical Care/trends , Pandemics , Critical Care/organization & administration , Disaster Planning , Humans , Intensive Care Units/organization & administration , Monitoring, Physiologic/instrumentation , Monitoring, Physiologic/methods , Personal Protective Equipment , Surge Capacity , Telemedicine , Workflow
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