Outcomes of noninvasive ventilation as the ceiling of treatment in patients with COVID-19.

BACKGROUND: Non-invasive mechanical ventilation (NIV) is effective for symptom relief and respiratory support in patients with respiratory insufficiency, severe comorbidities and no indication to intubation. Experience with NIV as the ceiling of treatment in severely compromised novel coronavirus disease (COVID-19) patients is lacking. METHODS: We evaluated 159 patients with COVID-19-related acute respiratory syndrome (ARDS), 38 of whom with NIV as the ceiling of treatment, admitted to an ordinary ward and treated with continuous positive airway pressure (CPAP) and respiratory physiotherapy. Treatment failure and death were correlated with clinical and laboratory parameters in the whole cohort and in patients with NIV as the ceiling of treatment. RESULTS: Patients who had NIV as the ceiling of treatment were elderly, with a low BMI and a high burden of comorbidities, showed clinical and laboratory signs of multiorgan insufficiency on admission and of rapidly deteriorating vital signs during the first week of treatment. NIV failure occurred overall in 77 (48%) patients, and 27/38 patients with NIV as the ceiling of treatment died. Congestive heart failure, chronic benign hematological diseases and inability/refusal to receive respiratory physiotherapy were independently associated to NIV failure and mortality. Need for increased positive end-expiratory pressures and low platelets were associated with NIV failure. Death was associated to cerebrovascular disease, need for CPAP cycles longer than 12 h and, in the subgroup of patients with NIV as the ceiling of treatment, was heralded by vital sign deterioration within 48 h. CONCLUSIONS: NIV and physiotherapy are a viable treatment option for patients with severe COVID-19 and severe comorbidities.

Percutaneous tracheostomy in COVID-19 patients: a new apneic approach.

BACKGROUND: Percutaneous dilation tracheostomy is an aerosol-generating procedure carrying a documented infectious risk during respiratory virus pandemics. For this reason, during the COVID-19 outbreak, surgical tracheostomy was preferred to the percutaneous one, despite the technique related complications increased risk. METHODS: We describe a new sequence for percutaneous dilation tracheostomy procedure that could be considered safe both for patients and healthcare personnel. A fiberscope was connected to a video unit to allow bronchoscopy. Guidewire positioning was performed as usual. While the established standard procedure continues with the creation of the stoma without any change in mechanical ventilation, we retracted the bronchoscope until immediately after the access valve in the mount tube, allowing normal ventilation. After 3 minutes of ventilation with 100% oxygen, mechanical ventilation was stopped without disconnecting the circuit. During apnea, the stoma was created by dilating the trachea and the tracheostomy cannula was inserted. Ventilation was then resumed. We evaluated the safeness of the procedure by recording any severe desaturation and by performing serological tests to all personnel. RESULTS: Thirty-six patients (38%) of 96 underwent tracheostomy; 22 (23%) percutaneous dilation tracheostomies with the new approach were performed without any desaturation. All personnel (150 operators) were evaluated for serological testing: 9 (6%) had positive serology but none of them had participated in tracheostomy procedures. CONCLUSION: This newly described percutaneous dilation tracheostomy technique was not related to severe desaturation events and we did not observe any positive serological test in health workers who performed the tracheostomies.

COVID-19 second wave: appropriateness of admissions to the Emergency Department of a main metropolitan hospital in Milan.

BACKGROUND: In Europe, Italy and Lombardy, in autumn 2020, there was a steep increase in reported cases due to the second epidemic wave of SARS-Cov-2 infection. We aimed to evaluate the appropriateness of COVID-19 patients' admissions to the ED of the San Raffaele Hospital. METHODS: We compared data between the inter-wave period (IWP, from 1st to 30th September) and the second wave period (WP, 1st October to 15th November) focusing on the ED presentation, discharge priority colour code and outcomes. RESULTS: Out of 977 admissions with a SARS-Cov-2 positive swab, 6% were in the IWP and 94% in the WP. Red, yellow and white code increased (these latter from 1.8% to 5.4%) as well as self-presented in yellow and white code. Discharges home increased from 1.8% to 5.4%, while hospitalizations decreased from 63% to 51%. DISCUSSION: We found a rise in white codes (among self-presented patients), indicating inappropriateness of admissions. The increase in discharges suggests that several patients did not require hospitalization. CONCLUSIONS: The pandemic brought out the fundamental role of primary care to manage patients with low-intensity needs. The important increase in ED admissions of COVID-19 patients caused a reduction of NO-COVID-19 patients, with possible inadequate treatment.

Continuous infusion versus intermittent administration of meropenem in critically ill patients (MERCY): A multicenter randomized double-blind trial. Rationale and design.

OBJECTIVE: Meropenem is a ß-lactam, carbapenem antibacterial agent with antimicrobial activity against gram-negative, gram-positive and anaerobic micro-organisms and is important in the empirical treatment of serious infections in Intensive Care Unit (ICU) patients. Multi-drug resistant gram-negative organisms, coupled with scarcity of new antibiotic classes, forced healthcare community to optimize the therapeutic potential of available antibiotics. Our aim is to investigate the effect of continuous infusion of meropenem against bolus administration, as indicated by a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens in a population of ICU patients. DESIGN: Double blind, double dummy, multicenter randomized controlled trial (1:1 allocation ratio). SETTING: Tertiary and University hospitals. INTERVENTIONS: 600 ICU patients with sepsis or septic shock, needing by clinical judgment antibiotic therapy with meropenem, will be randomized to receive a continuous infusion of meropenem 3 g/24 h or an equal dose divided into three daily boluses (i.e. 1g q8h). MEASUREMENTS: The primary endpoint will be a composite outcome of reducing death and emergence of extensive or pan drug-resistant pathogens. Secondary endpoints will be death from any cause at day 90, antibiotic-free days at day 28, ICU-free days at day 28, cumulative SOFA-free (Sequential Organ Failure Assessment) score from randomization to day 28 and the two, separate, components of the primary endpoint. We expect a primary outcome reduction from 52 to 40% in the continuous infusion group. CONCLUSIONS: The trial will provide evidence for choosing intermittent or continuous infusion of meropenem for critically ill patients with multi-drug resistant gram-negative infections.

Tracheal intubation in patients at risk for cervical spinal cord injury: A systematic review.

BACKGROUND: Tracheal intubation in patients at risk for secondary spinal cord injury is potentially difficult and risky. OBJECTIVES: To compare tracheal intubation techniques in adult patients at risk for secondary cervical spinal cord injury undergoing surgery. Primary outcome was first-attempt failure rate. Secondary outcomes were time to successful intubation and procedure complications. DESIGN: Systematic review and meta-analysis of randomized controlled trials (RCTs) with trial sequential analysis (TSA). DATA SOURCES: Databases searched up to July 2019. ELIGIBILITY: Randomized controlled trials comparing different intubation techniques. RESULTS: We included 18 trials enrolling 1972 patients. Four studies used the "awake" approach, but no study compared awake versus non-awake techniques. In remaining 14 RCTs, intubation was performed under general anesthesia. First-attempt failure rate was similar when comparing direct laryngoscopy or fiberoptic bronchoscopy versus other techniques. A better first-attempt failure rate was found with videolaryngoscopy and when pooling all the fiberoptic techniques together. All these results appeared not significant at TSA, suggesting inconclusive evidence. Intubating lighted stylet allowed faster intubation. Postoperative neurological complications were 0.34% (no significant difference among techniques). No life-threatening adverse event was reported; mild local complications were common (19.5%). The certainty of evidence was low to very low mainly due to high imprecision and indirectness. CONCLUSIONS: Videolaryngoscopy and fiberoptic-assisted techniques might be associated with higher first-attempt failure rate over controls. However, low to very low certainty of evidence does not allow firm conclusions on the best tracheal intubation in patients at risk for cervical spinal cord injury.

Noninvasive ventilation and survival in acute care settings: a comprehensive systematic review and metaanalysis of randomized controlled trials.

OBJECTIVE: Noninvasive ventilation is increasingly applied to prevent or treat acute respiratory failure, but its benefit on survival is still controversial for many indications. We performed a metaanalysis of randomized controlled trials focused on the effect of noninvasive ventilation on mortality. DATA SOURCES: BioMedCentral, PubMed, Embase, and the Cochrane Central Register of clinical trials (updated December 31, 2013) were searched. STUDY SELECTION: We included all the randomized controlled trials published in the last 20 years performed in adults, reporting mortality, comparing noninvasive ventilation to any other treatment for prevention or treatment of acute respiratory failure or as a tool allowing an earlier extubation. Studies with unclear methodology, comparing two noninvasive ventilation modalities, or in palliative settings were excluded. DATA EXTRACTION: We extracted data on mortality, study design, population, clinical setting, comparator, and follow-up duration. DATA SYNTHESIS: Seventy-eight studies were analyzed. Noninvasive ventilation was associated with a reduction in mortality (12.6% in the noninvasive ventilation group vs 17.8% in the control arm; risk ratio=0.73 [0.66-0.81]; p<0.001; number needed to treat=19 with 7,365 patients included) at the longest available follow-up. Mortality was reduced when noninvasive ventilation was used to treat (14.2% vs 20.6%; risk ratio=0.72; p<0.001; number needed to treat=16, with survival improved in pulmonary edema, chronic obstructive pulmonary disease exacerbation, acute respiratory failure of mixed etiologies, and postoperative acute respiratory failure) or to prevent acute respiratory failure (5.3% vs 8.3%; risk ratio=0.64 [0.46-0.90]; number needed to treat=34, with survival improved in postextubation ICU patients), but not when used to facilitate an earlier extubation. Overall results were confirmed for hospital mortality. Patients randomized to noninvasive ventilation maintained the survival benefit even in studies allowing crossover of controls to noninvasive ventilation as rescue treatment. CONCLUSIONS: This comprehensive metaanalysis suggests that noninvasive ventilation improves survival in acute care settings. The benefit could be lost in some subgroups of patients if noninvasive ventilation is applied late as a rescue treatment. Whenever noninvasive ventilation is indicated, an early adoption should be promoted.

Intrathecal lactate concentration and spinal cord injury in thoracoabdominal aortic surgery.

OBJECTIVE: The aim of this study was to evaluate the role of lactate as an early predictor of spinal cord injury during thoracoabdominal aortic aneurysm repair. DESIGN: Observational study. SETTING: University hospital. PARTICIPANTS: Sixteen consecutive patients (10 men and 6 women) scheduled to undergo thoracoabdominal aortic aneurysm repair were enrolled in the study. All patients were affected by atherosclerotic aneurysmal pathology. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: During surgery, the authors simultaneously withdrew samples of cerebrospinal fluid and arterial blood to evaluate pO(2), pCO(2), pH, and lactate concentration. Samples were collected at 5 fixed times during and after surgery: T1 (before aortic cross-clamping), T2 (15 minutes after clamping), T3 (just before unclamping), T4 (end of surgery), and T5 (4 hours after the end of surgery). Lactate levels in cerebrospinal fluid rose consistently during aortic cross-clamping (T1 = 1.89 mmol/L, T2 = 2.21 mmol/L, T3 = 2.88 mmol/L, T4 = 3.655 mmol/L, and T5 = 3.16 mmol/L). Lactate concentrations in the cerebrospinal fluid were significantly higher in the 4 patients who developed neurologic injury, even at T1 (before surgery), than in those who did not end in spinal cord injury with the 4 highest values belonging to the 4 patients who later developed spinal cord injury. CONCLUSIONS: This study has the potential to elucidate the time course of early lactate level elevation during thoracoabdominal aortic aneurysm repair and its clinical use in predicting the development of postoperative spinal cord injury.

Cardiac index validation using the pressure recording analytic method in unstable patients.

OBJECTIVE: The authors investigated the accuracy and precision of the pressure recording analytic method (PRAM) in cardiac index measurement compared with thermodilution in unstable patients, a setting in which minimally invasive monitoring devices often fail. DESIGN: Criterion standard. SETTING: Intensive care unit. PATIENTS: Thirty-two consecutive patients with low cardiac output syndrome treated with an intra-aortic balloon pump and/or high doses of inotropic drugs but without atrial fibrillation were studied after cardiac surgery. INTERVENTIONS: None. Pulmonary and radial artery catheters were already in situ for clinical reasons. MEASUREMENTS AND MAIN RESULTS: Four patients (12.5%) were excluded from the study because of artifacts caused by under- or overdamping of the arterial pressure monitoring system. The authors performed 3 injections of the thermal indicator in 5 minutes through the pulmonary artery catheter. Mean cardiac index values of 12 consecutive beats were considered for the PRAM. A significant correlation was found between the cardiac index assessed by thermodilution and PRAM (r = 0.72, p < 0.001). The mean bias between the 2 techniques was 0.072 +/- 0.41 L/min/m(2) with lower and upper 95% limits of confidence of -0.089 and 0.233 L/min/m(2), respectively. The percentage error was 30%. Sufficient agreement between the two techniques was evidenced by the Bland-Altman plot with only two points above the limits of agreement. CONCLUSIONS: This study showed that PRAM, a minimally invasive method for cardiac index assessment, is clinically useful even in unstable patients such as those receiving intra-aortic balloon pump and/or ongoing high doses of a inotropic drugs because of a low cardiac output syndrome but without atrial fibrillation.