PDF(Pubmed)
Abstract：
BACKGROUND: A few prospective trials and case series have suggested that hyperbaric oxygen therapy (HBOT) may be efficacious for the treatment of severe COVID-19, but safety is a concern for critically ill patients. We present an interim analysis of the safety of HBOT via a randomized controlled trial (COVID-19-HBO).
METHODS: A randomized controlled, open-label, clinical trial was conducted in compliance with good clinical practice to explore the safety and efficacy of HBOT for severe COVID-19 in critically ill patients with moderate acute respiratory distress syndrome (ARDS). Between 3 June 2020, and 17 May 2021, 31 patients with severe COVID-19 and moderate-to-severe ARDS, a ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) < 26.7 kPa (200 mmHg), and at least two defined risk factors for intensive care unit (ICU) admission and/or mortality were enrolled in the trial and randomized 1:1 to best practice, or HBOT in addition to best practice. The subjects allocated to HBOT received a maximum of five treatments at 2.4 atmospheres absolute (ATA) for 80 min over seven days. The subjects were followed up for 30 days. The safety endpoints were analyzed.
RESULTS: Adverse events (AEs) were common. Hypoxia was the most common adverse event reported. There was no statistically significant difference between the groups. Numerically, serious adverse events (SAEs) and barotrauma were more frequent in the control group, and the differences between groups were in favor of the HBOT in PaO2/FiO2 (PFI) and the national early warning score (NEWS); statistically, however, the differences were not significant at day 7, and no difference was observed for the total oxygen burden and cumulative pulmonary oxygen toxicity dose (CPTD).
CONCLUSIONS: HBOT appears to be safe as an intervention for critically ill patients with moderate-to-severe ARDS induced by COVID-19.
BACKGROUND: NCT04327505 (31 March 2020) and EudraCT 2020-001349-37 (24 April 2020).
METHODS: A randomized controlled, open-label, clinical trial was conducted in compliance with good clinical practice to explore the safety and efficacy of HBOT for severe COVID-19 in critically ill patients with moderate acute respiratory distress syndrome (ARDS). Between 3 June 2020, and 17 May 2021, 31 patients with severe COVID-19 and moderate-to-severe ARDS, a ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) < 26.7 kPa (200 mmHg), and at least two defined risk factors for intensive care unit (ICU) admission and/or mortality were enrolled in the trial and randomized 1:1 to best practice, or HBOT in addition to best practice. The subjects allocated to HBOT received a maximum of five treatments at 2.4 atmospheres absolute (ATA) for 80 min over seven days. The subjects were followed up for 30 days. The safety endpoints were analyzed.
RESULTS: Adverse events (AEs) were common. Hypoxia was the most common adverse event reported. There was no statistically significant difference between the groups. Numerically, serious adverse events (SAEs) and barotrauma were more frequent in the control group, and the differences between groups were in favor of the HBOT in PaO2/FiO2 (PFI) and the national early warning score (NEWS); statistically, however, the differences were not significant at day 7, and no difference was observed for the total oxygen burden and cumulative pulmonary oxygen toxicity dose (CPTD).
CONCLUSIONS: HBOT appears to be safe as an intervention for critically ill patients with moderate-to-severe ARDS induced by COVID-19.
BACKGROUND: NCT04327505 (31 March 2020) and EudraCT 2020-001349-37 (24 April 2020).
摘要：
背景：一些前瞻性试验和病例系列表明，高压氧治疗（HBOT）可能对治疗重症COVID-19有效，但对于危重患者，安全性是一个问题。我们通过一项随机对照试验(COVID-19-HBO)对HBOT的安全性进行了中期分析。
方法：随机对照，开放标签，为了探讨HBOT治疗中度急性呼吸窘迫综合征（ARDS）危重患者的重度COVID-19的安全性和有效性，按照良好的临床实践进行了临床试验。2020年6月3日至2021年5月17日，31例重度COVID-19和中重度ARDS患者，动脉氧分压与吸入氧气分数的比值（PaO2/FiO2）<26.7kPa（200mmHg），和至少两个确定的重症监护病房（ICU）入院和/或死亡率的危险因素纳入试验，并随机1：1到最佳实践，或HBOT除了最佳实践。分配给HBOT的受试者在7天内在2.4个绝对大气压(ATA)下接受最多5次治疗,持续80分钟。受试者随访30天。对安全性终点进行分析。
结果：不良事件（AE）很常见。缺氧是最常见的不良事件。组间无统计学意义差异。数字上,严重不良事件（SAE）和气压伤在对照组中更常见，且组间差异有利于HBOT中PaO2/FiO2(PFI)和国家早期预警评分(NEWS);统计学上,然而,第7天时差异不显著,总氧负荷和累积肺氧毒性剂量(CPTD)无差异.
结论：HBOT作为COVID-19诱发的中重度ARDS的危重患者的干预措施似乎是安全的。
背景：NCT04327505（2020年3月31日）和EudraCT2020-001349-37（2020年4月24日）。
方法：随机对照，开放标签，为了探讨HBOT治疗中度急性呼吸窘迫综合征（ARDS）危重患者的重度COVID-19的安全性和有效性，按照良好的临床实践进行了临床试验。2020年6月3日至2021年5月17日，31例重度COVID-19和中重度ARDS患者，动脉氧分压与吸入氧气分数的比值（PaO2/FiO2）<26.7kPa（200mmHg），和至少两个确定的重症监护病房（ICU）入院和/或死亡率的危险因素纳入试验，并随机1：1到最佳实践，或HBOT除了最佳实践。分配给HBOT的受试者在7天内在2.4个绝对大气压(ATA)下接受最多5次治疗,持续80分钟。受试者随访30天。对安全性终点进行分析。
结果：不良事件（AE）很常见。缺氧是最常见的不良事件。组间无统计学意义差异。数字上,严重不良事件（SAE）和气压伤在对照组中更常见，且组间差异有利于HBOT中PaO2/FiO2(PFI)和国家早期预警评分(NEWS);统计学上,然而,第7天时差异不显著,总氧负荷和累积肺氧毒性剂量(CPTD)无差异.
结论：HBOT作为COVID-19诱发的中重度ARDS的危重患者的干预措施似乎是安全的。
背景：NCT04327505（2020年3月31日）和EudraCT2020-001349-37（2020年4月24日）。
