Effect of High-Flow Oxygen Therapy vs Conventional Oxygen Therapy on Invasive Mechanical Ventilation and Clinical Recovery in Patients With Severe COVID-19
Gustavo A. Ospina‐Tascón, Luis Calderón, Alberto Garcı́a, Virginia Zarama, Freddy Gómez-Álvarez, Tatiana Álvarez-Saa, Stephania Pardo-Otálvaro, Diego F. Bautista-Rincón, Mónica Vargas, José L. Aldana-Díaz, Ángela Marulanda, Alejandro Gutiérrez, Janer Varón, Mónica Liébana Gómez, María Elena Ochoa, E. Cidoncha Escobar, Mauricio Umaña, Julio Díez-Sepúlveda, Gabriel J. Tobón, Ludwig L. Albornóz, Carlos Celemín, Guillermo Ortíz, Eder Cáceres, Luis Felipe Reyes, Lucas Petri Damiani, Alexandre Biasi Cavalcanti, HiFLo-Covid Investigators, Fernando Rosso, Pablo Andrés Moncada, Sandra Carvajal, Julián Yara, Alejandro Jiménez, Alex Sotomayor, Maria I. Prieto, Daniel Loaiza López, Camilo Medina, Ana María Ángel‐Isaza, Natalia Giraldo, Freddy Watts, Tatiana Morell, Jorge Armando Revelo, David Paz, Wilson Villamil, Nicolás Orozco, Cristhian C. Rojas, Diana Martínez, Á. Sánchez, Liliana Vallecilla, Jenny A. Sandoval, Ana M. Crispín, Katherine Carvajal, L.V. Maldonado Romero, Nicol Guarín
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.