Dataset Information

Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19: A Randomized Clinical Trial.

ABSTRACT:

Importance

The effect of high-flow oxygen therapy vs conventional oxygen therapy has not been established in the setting of severe COVID-19.

Objective

To determine the effect of high-flow oxygen therapy through a nasal cannula compared with conventional oxygen therapy on need for endotracheal intubation and clinical recovery in severe COVID-19.

Design, setting, and participants

Randomized, open-label clinical trial conducted in emergency and intensive care units in 3 hospitals in Colombia. A total of 220 adults with respiratory distress and a ratio of partial pressure of arterial oxygen to fraction of inspired oxygen of less than 200 due to COVID-19 were randomized from August 2020 to January 2021, with last follow-up on February 10, 2021.

Interventions

Patients were randomly assigned to receive high-flow oxygen through a nasal cannula (n = 109) or conventional oxygen therapy (n = 111).

Main outcomes and measures

The co-primary outcomes were need for intubation and time to clinical recovery until day 28 as assessed by a 7-category ordinal scale (range, 1-7, with higher scores indicating a worse condition). Effects of treatments were calculated with a Cox proportional hazards model adjusted for hypoxemia severity, age, and comorbidities.

Results

Among 220 randomized patients, 199 were included in the analysis (median age, 60 years; n = 65 women [32.7%]). Intubation occurred in 34 (34.3%) randomized to high-flow oxygen therapy and in 51 (51.0%) randomized to conventional oxygen therapy (hazard ratio, 0.62; 95% CI, 0.39-0.96; P = .03). The median time to clinical recovery within 28 days was 11 (IQR, 9-14) days in patients randomized to high-flow oxygen therapy vs 14 (IQR, 11-19) days in those randomized to conventional oxygen therapy (hazard ratio, 1.39; 95% CI, 1.00-1.92; P = .047). Suspected bacterial pneumonia occurred in 13 patients (13.1%) randomized to high-flow oxygen and in 17 (17.0%) of those randomized to conventional oxygen therapy, while bacteremia was detected in 7 (7.1%) vs 11 (11.0%), respectively.

Conclusions and relevance

Among patients with severe COVID-19, use of high-flow oxygen through a nasal cannula significantly decreased need for mechanical ventilation support and time to clinical recovery compared with conventional low-flow oxygen therapy.

Trial registration

ClinicalTrials.gov Identifier: NCT04609462.

SUBMITTER: Ospina-Tascon GA

PROVIDER: S-EPMC8652598 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Publications

Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19: A Randomized Clinical Trial.

Ospina-Tascón Gustavo A GA Calderón-Tapia Luis Eduardo LE García Alberto F AF Zarama Virginia V Gómez-Álvarez Freddy F Álvarez-Saa Tatiana T Pardo-Otálvaro Stephania S Bautista-Rincón Diego F DF Vargas Mónica P MP Aldana-Díaz José L JL Marulanda Ángela Á Gutiérrez Alejandro A Varón Janer J Gómez Mónica M Ochoa María E ME Escobar Elena E Umaña Mauricio M Díez Julio J Tobón Gabriel J GJ Albornoz Ludwig L LL Celemín Flórez Carlos Augusto CA Ruiz Guillermo Ortiz GO Cáceres Eder Leonardo EL Reyes Luis Felipe LF Damiani Lucas Petri LP Cavalcanti Alexandre B AB

JAMA 20211201 21

<h4>Importance</h4>The effect of high-flow oxygen therapy vs conventional oxygen therapy has not been established in the setting of severe COVID-19.<h4>Objective</h4>To determine the effect of high-flow oxygen therapy through a nasal cannula compared with conventional oxygen therapy on need for endotracheal intubation and clinical recovery in severe COVID-19.<h4>Design, setting, and participants</h4>Randomized, open-label clinical trial conducted in emergency and intensive care units in 3 hospit ...[more]

PMID: 34874419

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Project description:BackgroundHigh-flow nasal cannula oxygen (HFNC) is a relatively new therapy used in adults with respiratory failure. Whether it is superior to conventional oxygen therapy (COT) or to noninvasive mechanical ventilation (NIV) remains unclear. The aim of the present study was to investigate whether HFNC was superior to either COT or NIV in adult acute respiratory failure patients.MethodsA review of the literature was conducted from the electronic databases from inception up to 20 October 2016. Only randomized clinical trials comparing HFNC with COT or HFNC with NIV were included. The intubation rate was the primary outcome; secondary outcomes included the mechanical ventilation rate, the rate of escalation of respiratory support and mortality.ResultsEleven studies that enrolled 3459 patients (HFNC, n?=?1681) were included. There were eight studies comparing HFNC with COT, two comparing HFNC with NIV, and one comparing all three. HFNC was associated with a significant reduction in intubation rate (OR 0.52, 95% CI 0.34 to 0.79, P?=?0.002), mechanical ventilation rate (OR 0.56, 95% CI 0.33 to 0.97, P?=?0.04) and the rate of escalation of respiratory support (OR 0.45, 95% CI 0.31 to 0.67, P?<?0.0001) when compared to COT. There was no difference in mortality between HFNC and COT utilization (OR 1.01, 95% CI 0.67 to 1.53, P?=?0.96). When HFNC was compared to NIV, there was no difference in the intubation rate (OR 0.96; 95% CI 0.66 to 1.39, P?=?0.84), the rate of escalation of respiratory support (OR 1.00, 95% CI 0.77 to 1.28, P?=?0.97) or mortality (OR 0.85, 95% CI 0.43 to 1.68, P?=?0.65).ConclusionsCompared to COT, HFNC reduced the rate of intubation, mechanical ventilation and the escalation of respiratory support. When compared to NIV, HFNC showed no better outcomes. Large-scale randomized controlled trials are necessary to prove our findings.Trial registrationPROSPERO International prospective register of systematic reviews on May 25, 2016 registration no. CRD42016039581 .

Project description:BackgroundHigh-flow nasal oxygen cannula (HFNC) and noninvasive mechanical ventilation (NIV) can prevent reintubation in critically ill patients. However, their efficacy in post-extubated sepsis patients remains unclear. The objective of this study was to compare the efficacy of HFNC vs. NIV to prevent reintubation in post-extubated sepsis patients.MethodsWe conducted a single-centre, prospective, open-labelled, randomised controlled trial at the medical intensive care unit of Siriraj Hospital, Mahidol University, Bangkok, Thailand. Sepsis patients who had been intubated, recovered, and passed the spontaneous breathing trial were enrolled and randomly assigned in a 1:1 ratio to receive either HFNC or NIV support immediately after extubation. The primary outcome was rate of reintubation at 72 h after extubation.ResultsBetween 1st October 2017 and 31st October 2019, 222 patients were enrolled and 112 were assigned to the HFNC group and 110 to the NIV group. Both groups were well matched in baseline characteristics. The median [IQR] age of the HFNC group was 66 [50-77] vs. 65.5 [54-77] years in the NIV group. The most common causes of intubation at admission were shock-related respiratory failure (57.1% vs. 55.5%) and acute hypoxic respiratory failure (34.8% vs. 40.9%) in the HFNC and NIV groups, respectively. The duration of mechanical ventilation before extubation was 5 [3-8] days in the HFNC group vs. 5 [3-9] days in the NIV group. There was no statistically significant difference in the primary outcome: 20/112 (17.9%) in the HFNC group required reintubation at 72 h compared to 20/110 (18.2%) in the NIV group [relative risk (RR) 0.99: 95% confidence interval (CI) (0.70-1.39); P = 0.95]. The 28-day mortality was not different: 8/112 (7.1%) with HFNC vs. 10/110 (9.1%) with NIV (RR 0.88: 95% CI (0.57-1.37); P = 0.59).ConclusionsAmong sepsis patients, there was no difference between HFNC and NIV in the prevention of reintubation at 72 h after extubation. Clinical Trial Registration ClinicalTrials.gov Identifier: NCT03246893; Registered 11 August 2017; https://clinicaltrials.gov/ct2/show/NCT03246893?term=surat+tongyoo&draw=2&rank=3.

Project description:BackgroundPatients with difficult weaning who undergo mechanical ventilation are more likely to be at risk of reintubation and the sequential use of oxygen therapy after extubation is a concern for clinicians. Therefore, the aim of the present study was to compare the effects of transnasal high-flow nasal cannula (HFNC) oxygen therapy and non-invasive positive-pressure ventilation (NIV) on respiratory mechanics in patients with difficult weaning.MethodsThe present study was a single-center, retrospective, observational study. Twenty-nine patients with difficult weaning off invasive mechanical ventilation from the Department of Critical Care Medicine, The First Affiliated Hospital of Guangzhou Medical University, from December 2018 to April 2021, were included. Within 48 h after extubation, alternate respiratory support with HFNC and NIV was provided. Relevant indicators were recorded after each support mode had been maintained for at least 60 min. These included esophageal pressure (Pes), gastric pressure (Pga), transdiaphragmatic pressure (Pdi), pressure-time product of Pes (PTPes), pressure-time product of Pga (PTPga), pressure-time product of Pdi (PTPdi), ratio of the PTPdi to the PTPes (PTPdi/PTPes), and ratio of the Pes to the Pdi (Pes/Pdi), diaphragmatic electromyogram (EMGdi), percentage of esophageal pressure coefficient of variation (CVes%),diaphragmatic electromyogram coefficient of variation (CVEMG),inspiratory time (Ti), expiratory time (Te) and respiratory cycle time (Ttot).ResultsOf the 29 patients included, 22 were males and 7 were females [age: 63.97±15.34 years, Acute Physiological and Chronic Health Estimation II (APACHE II) score: 18.00±5.63]. The CVes% and the Pes/Pdi were significantly higher in patients with NIV than HFNC using 40 L/min, CVes%: 9 (-6, 20) vs. -7 (-23, 6) and Pes/Pdi: 0.17 (-0.1, 0.53), vs. -0.12 (-0.43, 0.08) (P<0.05). The remaining indicators were not statistically different.ConclusionsThe sequential NIV and HFNC can be tolerated in patients with such difficult weaning off mechanical ventilation after extubation, and more patients tend to choose HFNC subjectively. Compared with HFNC, NIV reduces the work of adjunctive respiratory muscle, but the patient's Pes dispersion is high when NIV is used, and it is necessary to pay attention to patient-ventilator coordination in clinical practice. We recommend alternating HFNC and NIV during the sequential respiratory therapy after extubation.

Project description:BackgroundAdequate respiratory support can improve clinical outcomes in patients who are ready for weaning from a ventilator. We aimed to investigate the efficacy of respiratory methods in adults undergoing planned extubation using a Bayesian network meta-analysis.MethodsWe searched PubMed, Embase, and ClinicalTrials.gov for unpublished and ongoing trials up to November 2019 for randomized controlled trials (RCTs) published in English that compared conventional oxygen therapy (COT), a high-flow nasal cannula (HFNC), and noninvasive ventilation (NIV) for post-extubation respiratory support. Screening of citations, study selection, data extraction, and assessment of risk were performed independently by two authors. The primary outcome was the reintubation rate.ResultsTwenty-two studies (4,218 patients) were included in our meta-analysis. Extubated patients supported with NIV had a significantly lower incidence of reintubation than those supported with COT [odds ratio (OR): 0.63, 95% confidence interval (CI): 0.42, 0.89]. However, there was no significant difference in the reintubation rate between the HFNC and NIV, and HFNC and COT groups (OR: 1.05, 95% CI: 0.60, 1.81; OR: 0.60, 95% CI: 0.33, 1.02, respectively). HFNC and NIV reduced the incidence of hospital-acquired pneumonia (HAP) (OR: 0.50, 95% CI: 0.25, 0.93; OR: 0.55, 95% CI: 0.27, 0.87, respectively) and post-extubation acute respiratory failure (ARF) (OR: 0.35, 95% CI: 0.14, 0.89; OR: 0.31, 95% CI: 0.14, 0.63, respectively) compared with COT. There was no significant difference in a decreased incidence of HAP (OR: 1.1, 95% CI: 0.56, 1.8) or post-extubation ARF (OR: 0.87, 95% CI: 0.33, 2.1) between NIV and HFNC. There were also no significant differences in improvements in other clinical outcomes, including intensive care unit (ICU) and hospital mortality and the length of stay (LOS) between NIV and HFNC.ConclusionsNIV reduces the reintubation rate in adult patients undergoing planned extubation compared with COT and HFNC.

Project description:BackgroundPostoperative pulmonary complications after esophagectomy still represent a matter of concern. High flow nasal cannula (HFNC) early after major abdominal and thoracic surgery has demonstrated some advantages over conventional oxygen therapy. Data about respiratory effect of HFNC after esophagectomy is scarce. The primary aim of this study is to investigate if the early use of HFNC after esophagectomy could enhance patients' postoperative respiratory oxygenation (ROX) index and, ultimately, reduce postoperative pneumonia.MethodsIn this single center retrospective study all patients undergoing to esophagectomy for cancer from May 2020 to November 2022 were evaluated. Historical cohort (HC) received postoperative oxygen supplementation with Venturi mask or nasal goggles, and a cohort was put under HFNC (HFNC cohort). ROX index, blood gas analysis, radiological atelectasis score (RAS), post-operative complications' data and information on hospital stay have been collected and analyzed.ResultsSeventy-one patients were included for the final statistical analysis, 31 in the HFNC and 40 in the HC cohort. Mean age was 64±10 years and body mass index (BMI) was 26 [24-29] kg/m2. ROX index was higher in the HFNC patients than in the HC, 20.8 [16.7-25.9] vs. 14.9 [10.8-18.2] (P<0.0001). In the HFNC cohort patients, pH was higher, 7.42 [7.40-7.44] vs. 7.39 [7.37-7.43] than HC, while PaCO2 was lower in HFNC cohort compared with HC, 39 [36-41] vs. 42 [39-45] mmHg, respectively (P=0.01). RAS was similar between the two cohorts of patients, 1.5±0.98 vs. 1.4±1.04 in the HFNC and the HC cohort, respectively (P=0.611). Lower acute respiratory failure (ARF) rate was recorded among HFNC than HC cohort, 0% vs. 13% respectively, P=0.06. No difference in pneumonia frequency between two cohorts was shown.ConclusionsHFNC improved the ROX index after esophagectomy through significant respiratory rate reduction. This tool should be considered for early respiratory support after extubation in this category of patients, not only as a rescue therapy for ARF, but also to optimize early postoperative respiratory function. Whether this will improve patients' outcomes requires further large randomized controlled trials.

Project description:BackgroundHypoxemia frequently occurs during bronchoscopy. High-flow nasal cannula (HFNC) oxygen therapy may be a feasible alternative to prevent the deterioration of gas exchange during bronchoscopy. With the convenience of clinical use in mind, we modified an HFNC using a single cannula. This clinical trial was designed to test the hypothesis that a modified HFNC would decrease the proportion of patients with a single moment of peripheral arterial oxygen saturation (SpO2) < 90% during bronchoscopy.MethodsIn this single-center, prospective randomized controlled trial, hospitalized patients in the respiratory department in need of diagnostic bronchoscopy were randomly assigned to a modified HFNC oxygen therapy group or a conventional oxygen therapy (COT) group. The primary outcome was the proportion of patients with a single moment of SpO2 < 90% during bronchoscopy.ResultsEight hundred and twelve patients were randomized to the modified HFNC (n = 406) or COT (n = 406) group. Twenty-four patients were unable to cooperate or comply with bronchoscopy. Thus, 788 patients were included in the analysis. The proportion of patients with a single moment of SpO2 < 90% during bronchoscopy in the modified HFNC group was significantly lower than that in the COT group (12.5% vs. 28.8%, p < 0.001). There were no significant differences in the fraction of inspired oxygen between the two groups. The lowest SpO2 during bronchoscopy and 5 min after bronchoscopy in the modified HFNC group was significantly higher than that in the COT group. Multivariate analysis showed that a baseline forced vital capacity (FVC) < 2.7 L (OR, 0.276; 95% CI, 0.083-0.919, p = 0.036) and a volume of fluid instilled > 60 ml (OR, 1.034; 95% CI, 1.002-1.067, p = 0.036) were independent risk factors for hypoxemia during bronchoscopy in the modified HFNC group.ConclusionsA modified HFNC could decrease the proportion of patients with a single moment of SpO2 < 90% during bronchoscopy. A lower baseline FVC and large-volume bronchoalveolar lavage may predict desaturation during bronchoscopy when using a modified HFNC. Trial registration ClinicalTrials. Gov: NCT02606188. Registered 17 November 2015.

Project description:BackgroundIn COVID-19 patients, older age (sixty or older), comorbidities, and frailty are associated with a higher risk for mortality and invasive mechanical ventilation (IMV) failure. It therefore seems appropriate to suggest limitations of care to older and vulnerable patients with severe COVID-19 pneumonia and a poor expected outcome, who would not benefit from invasive treatment. HFNO (high flow nasal oxygen) is a non-invasive respiratory support device already used in de novo acute respiratory failure. The main objective of this study was to evaluate the survival of patients treated with HFNO outside the ICU (intensive care unit) for a severe COVID-19 pneumonia, otherwise presenting limitations of care making them non-eligible for IMV. Secondary objectives were the description of our cohort and the identification of prognostic factors for HFNO failure.MethodsWe conducted a retrospective cohort study. We included all patients with limitations of care making them non-eligible for IMV and treated with HFNO for a severe COVID-19 pneumonia, hospitalized in a COVID-19 unit of the pulmonology department of Lyon Sud University Hospital, France, from March 2020 to March 2021. Primary outcome was the description of the vital status at day-30 after HFNO initiation, using the WHO (World Health Organization) 7-points ordinal scale.ResultsFifty-six patients were included. Median age was 83 years [76.3-87.0], mean duration for HFNO was 7.5 days, 53% had a CFS score (Clinical Frailty Scale) >4. At day-30, 73% of patients were deceased, one patient (2%) was undergoing HFNO, 9% of patients were discharged from hospital. HFNO failure occurred in 66% of patients. Clinical signs of respiratory failure before HFNO initiation (respiratory rate >30/min, retractions, and abdominal paradoxical breathing pattern) were associated with mortality (p = 0.001).ConclusionsWe suggest that HFNO is an option in non-ICU skilled units for older and frail patients with a severe COVID-19 pneumonia, otherwise non-suitable for intensive care and mechanical ventilation. Observation of clinical signs of respiratory failure before HFNO initiation was associated with mortality.

Dataset Information

Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19: A Randomized Clinical Trial.

Similar Datasets

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