1 Department of Pediatrics, University of Washington, Seattle, Washington.
2 Center for Child Health, Behavior, and Development, Seattle Children's Research Institute, Seattle, Washington.
Am J Respir Crit Care Med. 2018 Jun 1;197(11):1457-1467. doi: 10.1164/rccm.201708-1768OC.
Whether a nurse-implemented goal-directed sedation protocol resulting in more awake yet calm intubated children affects postdischarge functional status, health-related quality of life, or risk for post-traumatic stress disorder is unknown.
To compare postdischarge outcomes in children with acute respiratory failure cluster-randomized to a sedation protocol or usual care.
A stratified random sample of 1,360 patients from 31 centers in the RESTORE (Randomized Evaluation of Sedation Titration for Respiratory Failure) trial was assessed by mail, electronically, and/or telephone 6 months after ICU discharge. In treatment group comparisons, we controlled for age, baseline functional status, and severity of illness.
We used the Pediatric Overall Performance Category and the Pediatric Cerebral Performance Category to characterize functional status, the Infant and Toddler Quality of Life Questionnaire (97-item full-length version) (<2 yr old) or Pediatric Quality of Life Inventory (≥2 yr old), and the Child Post-traumatic Stress Disorder Symptom Scale (≥8 yr old and developmentally able). Functional status worsened from baseline to follow-up in 20%. Decline in functional status did not differ by treatment arm and was more common among those with baseline impairment than those with baseline normal function (27 vs. 18%; P < 0.001). There were no significant differences in health-related quality of life total scores by treatment arm. Scores indicating risk of post-traumatic stress disorder occurred in 30%, with no difference between treatment arms.
A sedation strategy that allows patients to be more awake and exposes them to fewer sedative and analgesic medications produces no long-term harm. However, postdischarge morbidity after acute respiratory failure is common. Clinical trial registered with www.clinicaltrials.gov (NCT00814099).
采用护士实施的以目标为导向的镇静方案，使接受机械通气的患儿保持清醒但镇静程度适宜，是否会影响患儿出院后的功能状态、健康相关生活质量或创伤后应激障碍风险，目前尚不清楚。
比较急性呼吸衰竭患儿接受镇静方案或常规护理后，出院后的结局。
RESTE （随机评价呼吸衰竭镇静滴定）试验的 31 个中心入选了 1360 例患者，采用分层随机抽样方法，通过邮件、电子或电话的方式在患儿 ICU 出院后 6 个月进行评估。在治疗组比较中，我们对年龄、基线功能状态和疾病严重程度进行了控制。
我们采用儿童总体表现类别和儿童脑功能表现类别来描述功能状态，采用婴儿和学步儿童生活质量问卷（97 项全长度版本）（<2 岁）或儿科生活质量量表（≥2 岁），以及儿童创伤后应激障碍症状量表（≥8 岁且有发育能力）。20%的患儿从基线到随访时的功能状态恶化。功能状态的下降在治疗组之间没有差异，在基线有功能障碍的患儿中比在基线功能正常的患儿中更为常见（27%比 18%；P<0.001）。治疗组之间的健康相关生活质量总分没有显著差异。提示创伤后应激障碍风险的评分发生率为 30%，两组之间没有差异。
使患者更加清醒并减少镇静和镇痛药物暴露的镇静策略不会造成长期危害。然而，急性呼吸衰竭患儿出院后的发病率仍然很高。临床试验在 www.clinicaltrials.gov 注册（NCT00814099）。
