Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden; Medical Unit Intensive Care and Thoracic Surgery, Hyperbaric Medicine, Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
Department of Anaesthesia and Intensive Care, Blekingesjukhuset, Karlskrona, Sweden.
Respir Med. 2024 Oct;232:107744. doi: 10.1016/j.rmed.2024.107744. Epub 2024 Jul 24.
Few treatment options exist for patients with COVID-19-induced acute respiratory distress syndrome (ARDS). Data on the benefits and harms of hyperbaric oxygen treatment (HBOT) for this condition is limited.
To evaluate benefits and harms of HBOT in patients with COVID-19 induced ARDS.
In this open-label trial conducted at three hospitals in Sweden and Germany, patients with moderate to severe ARDS and at least two risk factors for unfavourable outcome, were randomly assigned (1:1) to medical oxygen 100 %, 2·4 Atmospheres absolute (ATA), 80 min (HBOT) adjuvant to best practice or to best practice alone (Control). Randomisation was stratified by sex and site. The primary endpoint was ICU admission by Day 30.
Between June 4, 2020, and Dec 1, 2021, 34 subjects were randomised to HBOT (N = 18) or Control (N = 16). The trial was prematurely terminated for futility. There was no statistically significant difference in ICU admission, 5 (50 %) in Control vs 13 (72 %) in HBOT. OR 2·54 [95 % CI 0·62-10·39], p = 0·19.
102 adverse events (AEs) were recorded. 16 (94 %) subjects in the HBOT group and 14 (93 %) in the control group had at least one AE. Three serious adverse events (SAEs), were at least, possibly related to HBOT. All deaths were unlikely related to HBOT.
HBOT did not reduce ICU admission or mortality in patients with COVID-19-induced ARDS. The trial cannot conclude definitive benefits or harms. Treating COVID-19-induced ARDS with HBOT is feasible with a favourable harms profile.
目前针对 COVID-19 引发的急性呼吸窘迫综合征（ARDS）患者，治疗选择有限。关于高压氧治疗（HBOT）对这种疾病的疗效和危害的数据有限。
评估 HBOT 对 COVID-19 诱导的 ARDS 患者的疗效和危害。
本研究为在瑞典和德国的三家医院进行的开放标签试验，纳入中度至重度 ARDS 且至少存在两种不良预后风险因素的患者，以 1:1 的比例随机分配（分层因素为性别和地点）接受 100%医用氧气、2.4 个大气压绝对（ATA）、80 分钟的 HBOT 辅助最佳治疗或仅接受最佳治疗（HBOT 组或对照组）。主要终点为第 30 天 ICU 收治情况。
2020 年 6 月 4 日至 2021 年 12 月 1 日，共有 34 名患者被随机分配至 HBOT 组（n=18）或对照组（n=16）。由于无效，试验提前终止。两组的 ICU 收治率无统计学差异，对照组为 5 例（50%），HBOT 组为 13 例（72%）。OR 2.54[95%CI 0.62-10.39]，p=0.19。
记录到 102 例不良事件（AE）。HBOT 组和对照组各有 16 例（94%）和 14 例（93%）至少发生 1 例 AE。HBOT 组有 3 例严重不良事件（SAE）至少可能与 HBOT 相关。所有死亡均不太可能与 HBOT 相关。
HBOT 并未降低 COVID-19 诱导的 ARDS 患者的 ICU 收治率或死亡率。该试验无法得出明确的获益或危害结论。使用 HBOT 治疗 COVID-19 诱导的 ARDS 是可行的，且具有良好的危害特征。
