Olsen Hanne T, Nedergaard Helene K, Hough Catherine L, Korkmaz Serkan, Jensen Hanne I, Strøm Thomas, Toft Palle
Department of Anesthesiology and Intensive Care, Odense University Hospital, Svendborg Hospital, Svendborg, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Acta Anaesthesiol Scand. 2021 Apr;65(4):481-488. doi: 10.1111/aas.13775. Epub 2021 Jan 18.
Critical illness is associated with severely impaired health-related quality of life (HRQoL) for years following discharge. The NONSEDA trial was a multicenter randomized trial on non-sedation versus sedation with a daily wake-up trial in critically ill, mechanically ventilated patients in Scandinavia. The aim of this sub-study was to assess the effect of non-sedation on HRQoL and degree of independence in activities in daily living (ADL) 3 months post-ICU.
All survivors were asked to complete the Medical Outcomes Study Short-Form 36 questionnaire (SF-36) and the Barthel Index 3 months post-ICU. To limit missing data, reminders were sent. If unsuccessful, telephone interviews could be used. Outcomes were the level of HRQoL and ADL-function in each group. All outcomes were assessed blinded.
Of the 700 patients included 412 survived to follow-up. A total of 344 survivors participated (82%). Baseline data were equal between the two groups. Mean SF-36 scores for the non-sedated vs sedated patients were as follows: Physical Function 45 vs 40, P = .69, Bodily Pain: 61 vs 52, P = .81, General Health: 50 vs 50, P = .84, Vitality: 42 vs 44, P = .85, Social Function: 75 vs 63, P = .85, Role Emotional: 58 vs 50, P = .82, Mental Health: 70 vs 70, P = .89, Role Physical: 25 vs 28, P = .32, Physical Component Score: 38 vs 37, P = .81, Mental Component Score: 48 vs 46, P = .94, Barthel Index: 20 vs 20, P = .74.
Randomization to non-sedation neither improved nor impaired health-related quality of life or degree of independence in activities in daily living 3 months post-ICU discharge.
危重病与出院后数年严重受损的健康相关生活质量（HRQoL）相关。NONSEDA试验是一项在斯堪的纳维亚半岛对危重症机械通气患者进行的非镇静与镇静及每日唤醒试验的多中心随机试验。本亚研究的目的是评估非镇静对ICU出院后3个月时HRQoL及日常生活活动（ADL）独立性程度的影响。
所有幸存者均被要求在ICU出院后3个月完成医学结局研究简明健康调查问卷（SF-36）和巴氏指数。为减少数据缺失，发送了提醒。若未成功，可采用电话访谈。结局指标为每组的HRQoL水平和ADL功能。所有结局指标的评估均采用盲法。
纳入的700例患者中，412例存活至随访。共有344例幸存者参与（82%）。两组间基线数据相当。非镇静组与镇静组患者的SF-36平均得分如下：生理功能45对40，P = 0.69；身体疼痛61对52，P = 0.81；总体健康50对50，P = 0.84；活力42对44，P = 0.85；社会功能75对63，P = 0.85；角色情感58对50，P = 0.82；心理健康70对70，P = 0.89；角色生理25对28，P = 0.32；生理成分得分38对37，P = 0.81；心理成分得分48对46，P = 0.94；巴氏指数20对20，P = 0.74。
随机分组至非镇静组在ICU出院后3个月时既未改善也未损害健康相关生活质量或日常生活活动的独立程度。
