Martin Daniel S, McNeil Margaret, Brew-Graves Chris, Filipe Helder, O'Driscoll Ronan, Stevens Jia Liu, Burnish Rachel, Cumpstey Andrew F, Williams Norman R, Mythen Michael G, Grocott Michael Pw
Intensive Care Unit, Royal Free Hospital, Pond Street, London, UK.
Peninsula Medical School, University of Plymouth, Plymouth, UK.
J Intensive Care Soc. 2021 Nov;22(4):280-287. doi: 10.1177/17511437211010031. Epub 2021 Apr 8.
Despite oxygen being the commonest drug administered to critically ill patients we do not know which oxygen saturation (SpO) target results in optimal survival outcomes in those receiving mechanical ventilation. We therefore conducted a feasibility randomised controlled trial in the United Kingdom (UK) to assess whether it would be possible to host a larger national multi-centre trial to evaluate oxygenation targets in mechanically ventilated patients.
We set out to recruit 60 participants across two sites into a trial in which they were randomised to receive conservative oxygenation (SpO 88-92%) or usual care (control - SpO ≥96%). The primary outcome was feasibility; factors related to safety and clinical outcomes were also assessed.
A total of 34 patients were recruited into the study until it was stopped due to time constraints. A number of key barriers to success were identified during the course of the study. The conservative oxygenation intervention was feasible and appeared to be safe in this small patient cohort and it achieved wide separation of the median time-weighted average (IQR) SpO at 91% (90-92%) in conservative oxygenation group versus 97% (96-97%) in control group.
Whilst conservative oxygenation was a feasible and safe intervention which achieved clear group separation in oxygenation levels, the model used in this trial will require alterations to improve future participant recruitment rates in the UK.
尽管氧气是危重症患者最常用的药物,但我们并不清楚在接受机械通气的患者中,哪种氧饱和度(SpO)目标能带来最佳生存结果。因此,我们在英国进行了一项可行性随机对照试验,以评估是否有可能开展一项更大规模的全国多中心试验,来评估机械通气患者的氧合目标。
我们计划在两个地点招募60名参与者进行试验,将他们随机分为接受保守氧合(SpO 88 - 92%)或常规治疗(对照组 - SpO≥96%)。主要结局是可行性;还评估了与安全性和临床结局相关的因素。
由于时间限制,在研究停止前共招募了34名患者。在研究过程中发现了一些关键的成功障碍。保守氧合干预在这个小患者队列中是可行的,并且似乎是安全的,保守氧合组的中位时间加权平均(IQR)SpO为91%(90 - 92%),与对照组的97%(96 - 97%)有明显差异。
虽然保守氧合是一种可行且安全的干预措施,在氧合水平上实现了明确的组间分离,但本试验所采用的模式需要改进,以提高未来在英国的参与者招募率。