Churchill Susan, Deru Kayla, Weaver Lindell K, Wilson Steffanie H, Hebert Donald, Miller R Scott, Lindblad Anne S
Division of Hyperbaric Medicine, Intermountain Medical Center, Murray, Utah and Intermountain LDS Hospital, Salt Lake City, Utah U.S.
Department of Medicine, University of Utah School of Medicine, Salt Lake City, Utah U.S.
Undersea Hyperb Med. 2019;46(3):331-340.
Safety monitoring and successful blinding are important features of randomized, blinded clinical trials. We report chamber- and protocol-related adverse events (AEs) for participants enrolled in two randomized, double-blind clinical trials of hyperbaric oxygen (HBO2) for persistent post-concussive symptoms clinicaltrials.gov identifiers NCT01306968, HOPPS, and NCT01611194, BIMA), as well as the success of maintaining the blind with a low-pressure sham control arm. In both studies, participants were randomized to receive HBO2 (1.5 atmospheres absolute, >99% oxygen) or sham chamber sessions (1.2 atmospheres absolute, room air). In 143 participants undergoing 4,245 chamber sessions, chamber-related adverse events were rare (1.1% in the HOPPS study, 2.2% in the BIMA study). Minor, non-limiting barotrauma was the most frequently reported. Rarely, some participants experienced headache with chamber sessions. No serious adverse events were associated with chamber sessions. An allocation questionnaire completed after intervention revealed that the sham control arm adequately protected the blind in both trials. Participants based allocation assumptions on symptom improvement or lack of symptom improvement and could not discern intervention arm by pressure, smell, taste, or gas flow.
安全性监测和成功设盲是随机双盲临床试验的重要特征。我们报告了参与两项高压氧（HBO2）治疗持续性脑震荡后症状的随机双盲临床试验（clinicaltrials.gov标识符分别为NCT01306968，即HOPPS试验；以及NCT01611194，即BIMA试验）的受试者与舱室及方案相关的不良事件（AE），以及采用低压假对照臂维持设盲的成功情况。在这两项研究中，受试者被随机分配接受HBO2治疗（绝对压力1.5个大气压，氧气含量>99%）或假舱室治疗（绝对压力1.2个大气压，室内空气）。在143名受试者接受的4245次舱室治疗中，与舱室相关的不良事件很少见（HOPPS试验中为1.1%，BIMA试验中为2.2%）。最常报告的是轻微、无限制的气压伤。很少有受试者在舱室治疗时出现头痛。没有严重不良事件与舱室治疗相关。干预后完成的分配问卷显示，假对照臂在两项试验中都充分保护了设盲。受试者根据症状改善或未改善来进行分配假设，无法通过压力、气味、味道或气流辨别干预组。
