Nedergaard Helene Korvenius, Jensen Hanne Irene, Lauridsen Jørgen T, Sjøgaard Gisela, Toft Palle
Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, Skovvangen 2-8, DK-6000, Kolding, Denmark.
Department of Business and Economics, Centre of Health Economics research, University of Southern Denmark, Campusvej 55, DK-5230, Odense M, Denmark.
Trials. 2015 Jul 23;16:310. doi: 10.1186/s13063-015-0856-1.
Critically ill patients rapidly loose much of their muscle mass and strength. This can be attributed to prolonged admission, prolonged mechanical ventilation and increased mortality, and it can have a negative impact on the degree of independence and quality of life. In the NONSEDA trial we randomize critically ill patients to non-sedation or sedation with a daily wake-up trial during mechanical ventilation in the intensive care unit. It has never been assessed whether non-sedation affects physical function. The aim of this study is to assess the effects of non-sedation versus sedation with a daily wake-up trial on physical function after discharge from intensive care unit.
METHODS/DESIGN: Investigator-initiated, randomized, clinical, parallel-group, superiority trial, including 700 patients in total, with a substudy concerning 200 of these patients. Inclusion criteria will be intubated, mechanically ventilated patients with expected duration of mechanical ventilation >24 h. Exclusion criteria will be patients with severe head trauma, coma at admission or status epilepticus, patients treated with therapeutic hypothermia, patients with PaO2/FiO2<9 where sedation might be necessary to ensure sufficient oxygenation or placing the patient in a prone position. The experimental intervention will be non-sedation supplemented with pain management during mechanical ventilation. The control intervention will be sedation with a daily wake-up trial. The co-primary outcome will be quality of life regarding physical function (SF-36, physical component) and degree of independence in activities of daily living (Barthel Index), and this will be assessed for all 700 patients participating in the NONSEDA trial. The secondary outcomes, which will be assessed for the subpopulation of 200 NONSEDA patients in the trial site, Kolding, will be 6-min walking distance, handgrip strength, muscle size (ultrasonographic measurement of the rectus femoris muscle cross-sectional area) and biomechanical data on lower extremity function (maximal voluntary contraction, rate of force development and endurance).
This study is the first to investigate the effect of no sedation during critical illness on physical function. If an effect is found, it will add important information on how to prevent muscle weakness following critical illness.
The study has been approved by the relevant scientific ethics committee and is registered at ClinicalTrials.gov (ID: NCT02034942, 9 January 2014).
危重症患者会迅速丧失大量肌肉质量和力量。这可归因于住院时间延长、机械通气时间延长及死亡率增加，并且会对患者的独立程度和生活质量产生负面影响。在NONSEDA试验中，我们将危重症患者随机分为非镇静组或镇静组，在重症监护病房进行机械通气期间每天进行唤醒试验。此前从未评估过非镇静是否会影响身体功能。本研究的目的是评估非镇静与每天进行唤醒试验的镇静方式对重症监护病房出院后身体功能的影响。
方法/设计：由研究者发起的随机、临床、平行组、优效性试验，共纳入700例患者，其中200例患者进行一项子研究。纳入标准为经气管插管、机械通气且预计机械通气时间>24小时的患者。排除标准为严重颅脑外伤患者、入院时昏迷或癫痫持续状态患者、接受治疗性低温治疗的患者、动脉血氧分压/吸入氧浓度<9且可能需要镇静以确保充分氧合或使患者俯卧位的患者。实验性干预措施为机械通气期间非镇静并辅以疼痛管理。对照性干预措施为每天进行唤醒试验的镇静方式。共同主要结局指标为身体功能相关生活质量（SF-36身体维度）和日常生活活动的独立程度（Barthel指数），将对参与NONSEDA试验的所有700例患者进行评估。次要结局指标将在试验地点科灵的200例NONSEDA患者亚组中进行评估，包括6分钟步行距离、握力、肌肉大小（超声测量股直肌肌肉横截面积）以及下肢功能的生物力学数据（最大自主收缩、力量发展速率和耐力）。
本研究首次调查危重症期间不进行镇静对身体功能的影响。如果发现有影响，将为如何预防危重症后肌肉无力增添重要信息。
本研究已获得相关科学伦理委员会批准，并在ClinicalTrials.gov注册（编号：NCT02034942，2014年1月9日）。
