Research Department, Argentine Association of Hyperbaric Medicine and Research (AAMHEI), Buenos Aires, Argentina.
Laboratory of Arterial Hypertension, Cardiology Department, Hospital de Clinicas Jose de San Martin, Buenos Aires, Argentina.
Emerg Med J. 2022 Feb;39(2):88-93. doi: 10.1136/emermed-2021-211253. Epub 2021 Dec 14.
Hyperbaric oxygen (HBO) therapy has been proposed to treat hypoxaemia and reduce inflammation in COVID-19. Our objective was to analyse safety and efficacy of HBO in treatment of hypoxaemia in patients with COVID-19 and evaluate time to hypoxaemia correction.
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 (SpO ≤90% despite oxygen supplementation) were assigned to receive either HBO treatment or the standard treatment for respiratory symptoms for 7 days. HBO 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 SpO ≥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.
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; SpO was 85.1%±4.3% for the whole group. Patients in the treatment group received an average of 6.2±1.2 HBO 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 HBO 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.
Our findings support the safety and efficacy of HBO in the treatment of COVID-19 and severe hypoxaemia.
NCT04477954.
高压氧（HBO）治疗被提议用于治疗 COVID-19 患者的低氧血症并减轻炎症。我们的目的是分析 HBO 在治疗 COVID-19 患者低氧血症中的安全性和疗效，并评估低氧血症纠正的时间。
这是一项在阿根廷布宜诺斯艾利斯进行的多中心、开放性标签随机对照试验，于 2020 年 7 月至 11 月进行。患有 COVID-19 且严重低氧血症（即使给予氧疗，SpO2≤90%）的患者被随机分配接受 HBO 治疗或针对呼吸症状的标准治疗 7 天。计划对 HBO 治疗进行≥5 次（1/天），每次 90 分钟，压力为 1.45 个大气压绝对（ATA）。主要结局为 SpO2≥93%所需的氧疗时间正常化、需要机械通气支持、急性呼吸窘迫综合征的发生和 30 天内的死亡率。预计需要 80 名患者，计划在确定 50%患者的结局后进行中期分析。
在中期分析后，试验停止。共有 40 名患者被随机分配，每组 20 名，年龄为 55.2±9.2 岁。入院时，常见的症状是呼吸困难、发热和咽痛；全组 SpO2 为 85.1%±4.3%。治疗组患者平均接受 6.2±1.2 次 HBO 治疗。与对照组相比，治疗组纠正低氧血症的时间更短；中位数为 3 天（IQR 1.0-4.5）与中位数 9 天（IQR 5.5-12.5）（p<0.010）。与对照组相比，治疗组第 3 天的低氧血症恢复的 OR 为 23.2（95%CI 1.6 至 329.6；p=0.001）。治疗组在入院后 30 天内对急性呼吸窘迫综合征、机械通气或死亡没有统计学显著影响。
我们的研究结果支持 HBO 在治疗 COVID-19 和严重低氧血症中的安全性和疗效。
NCT04477954。
