Acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) is associated with substantial mortality and use of health care resources. Dexamethasone use might attenuate lung ...injury in these patients.
To determine whether intravenous dexamethasone increases the number of ventilator-free days among patients with COVID-19-associated ARDS.
Multicenter, randomized, open-label, clinical trial conducted in 41 intensive care units (ICUs) in Brazil. Patients with COVID-19 and moderate to severe ARDS, according to the Berlin definition, were enrolled from April 17 to June 23, 2020. Final follow-up was completed on July 21, 2020. The trial was stopped early following publication of a related study before reaching the planned sample size of 350 patients.
Twenty mg of dexamethasone intravenously daily for 5 days, 10 mg of dexamethasone daily for 5 days or until ICU discharge, plus standard care (n =151) or standard care alone (n = 148).
The primary outcome was ventilator-free days during the first 28 days, defined as being alive and free from mechanical ventilation. Secondary outcomes were all-cause mortality at 28 days, clinical status of patients at day 15 using a 6-point ordinal scale (ranging from 1, not hospitalized to 6, death), ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, and Sequential Organ Failure Assessment (SOFA) scores (range, 0-24, with higher scores indicating greater organ dysfunction) at 48 hours, 72 hours, and 7 days.
A total of 299 patients (mean SD age, 61 14 years; 37% women) were enrolled and all completed follow-up. Patients randomized to the dexamethasone group had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 2.26; 95% CI, 0.2-4.38; P = .04). At 7 days, patients in the dexamethasone group had a mean SOFA score of 6.1 (95% CI, 5.5-6.7) vs 7.5 (95% CI, 6.9-8.1) in the standard care group (difference, -1.16; 95% CI, -1.94 to -0.38; P = .004). There was no significant difference in the prespecified secondary outcomes of all-cause mortality at 28 days, ICU-free days during the first 28 days, mechanical ventilation duration at 28 days, or the 6-point ordinal scale at 15 days. Thirty-three patients (21.9%) in the dexamethasone group vs 43 (29.1%) in the standard care group experienced secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events.
Among patients with COVID-19 and moderate or severe ARDS, use of intravenous dexamethasone plus standard care compared with standard care alone resulted in a statistically significant increase in the number of ventilator-free days (days alive and free of mechanical ventilation) over 28 days.
ClinicalTrials.gov Identifier: NCT04327401.
The Enhanced Recovery After Surgery (ERAS) protocol affected traditional cardiac surgery processes and COVID-19 is expected to accelerate its scalability. The aim of this study was to assess the ...impact of an ERAS-based protocol on the length of hospital stay after cardiac surgery. From January 2019 to June 2020, 664 patients underwent consecutive cardiac surgery at a Latin American center. Here, 46 patients were prepared for a rapid recovery through a multidisciplinary institutional protocol based on the ERAS concept, the "TotalCor protocol". After the propensity score matching, 46 patients from the entire population were adjusted for 12 variables. Patients operated on the TotalCor protocol had reduced intensive care unit time (P < 0.025), postoperative stay (P ≤ 0.001) and length of hospital stay (P ≤ 0.001). In addition, there were no significant differences in the occurrence of complications and death between the two groups. Of the 10-central metrics of TotalCor protocol, 6 had > 70% adherences. In conclusion, the TotalCor protocol was safe and effective for a 3-day discharge after cardiac surgery. Postoperative atrial fibrillation and renal failure were predictors of postoperative stay > 5 days.
Purpose
Percutaneous dilational tracheostomy (PDT) is routinely performed in the intensive care unit with bronchoscopy guidance. Recently, ultrasound has emerged as a potentially useful tool to ...assist PDT and reduce procedure-related complications.
Methods
An open-label, parallel, non-inferiority randomized controlled trial was conducted comparing an ultrasound-guided PDT with a bronchoscopy-guided PDT in mechanically ventilated critically ill patients. The primary outcome was procedure failure, defined as a composite end-point of conversion to a surgical tracheostomy, unplanned associated use of bronchoscopy or ultrasound during PDT, or the occurrence of a major complication.
Results
A total of 4965 patients were assessed for eligibility. Of these, 171 patients were eligible and 118 underwent the procedure, with 60 patients randomly assigned to the ultrasound group and 58 patients to the bronchoscopy group. Procedure failure occurred in one (1.7 %) patient in the ultrasound group and one (1.7 %) patient in the bronchoscopy group, with no absolute risk difference between the groups (90 % confidence interval, −5.57 to 5.85), in the “as treated” analysis, not including the prespecified margin of 6 % for noninferiority. No other patient had any major complication in either group. Procedure-related minor complications occurred in 20 (33.3 %) patients in the ultrasound group and in 12 (20.7 %) patients in the bronchoscopy group (
P
= 0.122). The median procedure length was 11 7–19 vs. 13 8–20 min (
P
= 0.468), respectively, and the clinical outcomes were also not different between the groups.
Conclusions
Ultrasound-guided PDT is noninferior to bronchoscopy-guided PDT in mechanically ventilated critically ill patients.
Abstract Introduction Percutaneous dilational tracheostomy (PDT) is routinely performed in the intensive care unit with bronchoscopic guidance. Recently, ultrasound (US) has emerged as a new safety ...adjunct tool to increase the efficacy of PDT. However, the available data are limited to case series without any control group. Hence, a retrospective cohort study was designed to evaluate the efficacy of US-guided PDT compared with bronchoscopy-guided PDT. Methods All patients who were submitted to PDT after the standardization of US-guided PDT technique in our institution were analyzed. Demographic and procedure-related variables, complications, and clinical outcomes were collected and compared in patients undergoing US- or bronchoscopy-guided PDT. Results Sixty patients who had been submitted to PDT were studied, including 11 under bronchoscopy guidance and 49 under US guidance. No surgical conversion was necessary in any of the procedures, and bronchoscopy assistance was only required in 1 case in the US group. The procedure length was shorter in the US group than in the bronchoscopy group (12 vs 15 minutes, P = .028). None of the patients had any major complications. The minor complication rates were not significantly different between the groups, nor was the probability of breathing without assistance within 28 days, intensive care unit length of stay, or hospital mortality. Conclusion Ultrasound-guided PDT is effective, safe, and associated with similar complication rates and clinical outcomes compared with bronchoscopy-guided PDT.
The evidence of improved survival with the use of extracorporeal membrane oxygenation (ECMO) in acute respiratory distress syndrome is still uncertain.
This systematic review and meta-analysis was ...registered in the PROSPERO database with the number CRD-42018098618. We performed a structured search of Medline, Lilacs, and ScienceDirect for randomized controlled trials evaluating the use of ECMO associated with (ultra)protective mechanical ventilation for severe acute respiratory failure in adult patients. We used the Cochrane risk of bias tool to evaluate the quality of the evidence. Our primary objective was to evaluate the effect of ECMO on the last reported mortality. Secondary outcomes were treatment failure, hospital length of stay and the need for renal replacement therapy in both groups.
Two randomized controlled studies were included in the meta-analysis, comprising 429 patients, of whom 214 were supported with ECMO. The most common reason for acute respiratory failure was pneumonia (60% - 65%). Respiratory ECMO support was associated with a reduction in last reported mortality and treatment failure with risk ratios (RR: 0.76; 95%CI 0.61 - 0.95 and RR: 0.68; 95%CI 0.55 - 0.85, respectively). Extracorporeal membrane oxygenation reduced the need for renal replacement therapy, with a RR of 0.88 (95%CI 0.77 - 0.99). Intensive care unit and hospital lengths of stay were longer in ECMO-supported patients, with an additional P50th 14.84 (P25th - P75th: 12.49 - 17.18) and P50th 29.80 (P25th - P75th: 26.04 - 33.56 days, respectively.
Respiratory ECMO support in severe acute respiratory distress syndrome patients is associated with a reduced mortality rate and a reduced need for renal replacement therapy but a substantial increase in the lengths of stay in the intensive care unit and hospital. Our results may help bedside decision-making regarding ECMO initiation in patients with severe respiratory distress syndrome.