RT Journal Article
SR Electronic
T1 Hyperbaric oxygen as an adjuvant treatment for patients with COVID-19 severe hypoxaemia: a randomised controlled trial
JF Emergency Medicine Journal
JO Emerg Med J
FD BMJ Publishing Group Ltd and the British Association for Accident & Emergency Medicine
SP 88
OP 93
DO 10.1136/emermed-2021-211253
VO 39
IS 2
A1 Mariana Cannellotto
A1 Mariano Duarte
A1 Guillermo Keller
A1 Ramiro Larrea
A1 Eleonora Cunto
A1 Viviana Chediack
A1 Mariela Mansur
A1 Daniela M Brito
A1 Elizabeth García
A1 Héctor E Di Salvo
A1 Fabrizio Verdini
A1 Cecilia Domínguez
A1 Liliana Jorda-Vargas
A1 Javier Roberti
A1 Guillermo Di Girolamo
A1 Esteban Estrada
YR 2022
UL http://emj.bmj.com/content/39/2/88.abstract
AB Background Hyperbaric oxygen (HBO2) therapy has been proposed to treat hypoxaemia and reduce inflammation in COVID-19. Our objective was to analyse safety and efficacy of HBO2 in treatment of hypoxaemia in patients with COVID-19 and evaluate time to hypoxaemia correction.Methods This was a multicentre, open-label randomised controlled trial conducted in Buenos Aires, Argentina, between July and November 2020. Patients with COVID-19 and severe hypoxaemia (SpO2 ≤90% despite oxygen supplementation) were assigned to receive either HBO2 treatment or the standard treatment for respiratory symptoms for 7 days. HBO2 treatment was planned for ≥5 sessions (1 /day) for 90 min at 1.45 atmosphere absolute (ATA). Outcomes were time to normalise oxygen requirement to SpO2 ≥93%, need for mechanical respiratory assistance, development of acute respiratory distress syndrome and mortality within 30 days. A sample size of 80 patients was estimated, with a planned interim analysis after determining outcomes on 50% of patients.Results The trial was stopped after the interim analysis. 40 patients were randomised, 20 in each group, age was 55.2±9.2 years. At admission, frequent symptoms were dyspnoea, fever and odynophagia; SpO2 was 85.1%±4.3% for the whole group. Patients in the treatment group received an average of 6.2±1.2 HBO2 sessions. Time to correct hypoxaemia was shorter in treatment group versus control group; median 3 days (IQR 1.0–4.5) versus median 9 days (IQR 5.5–12.5), respectively (p<0.010). OR for recovery from hypoxaemia in the HBO2 group at day 3 compared with the control group was 23.2 (95% CI 1.6 to 329.6; p=0.001) Treatment had no statistically significant effect on acute respiratory distress syndrome, mechanical ventilation or death within 30 days after admission.Conclusion Our findings support the safety and efficacy of HBO2 in the treatment of COVID-19 and severe hypoxaemia.Trial registration number NCT04477954.Data are available on reasonable request. Additional information available on request to authors.