論文No1701
Long-Term Outcomes after Protocolized Sedation versus Usual Care in Ventilated Pediatric Patients
R. Scott Watson, Lisa A. Asaro, James H. Hertzog, Lauren R. Sorce, Alicia G. Kachmar, Leslie A. Dervan, Derek C. Angus, David Wypij, Martha A. Q. Curley, for the RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network
AJRCCM, Vol. 197, No. 11 | Jun 01, pp. 1457–1467, 2018
＜背景＞
挿管された小児が覚醒しつつも鎮静のままとなるナースによる目標指向の鎮静プロトコルによって、
退院後の機能、健康関連QOL、外傷後ストレス障害のリスクに影響があるかは不明である。
＜目的＞
急性呼吸不全の小児をクラスターランダム化し、鎮静プロトコルあるいは通常ケアで退院後の転帰を比較した。
＜方法＞
RESTORE (Randomized Evaluation of Sedation Titration for Respiratory Failure)に参加の３１の施設、1360名の小児の
層別化ランダムサンプルにおいて、ICU退室後6か月後にメールand/or電話で評価した。
治療群比較において、年齢、基礎的な機能状態、疾患重症度でコントロールした。
＜結果＞
Pediatric Overall Performance Category、Pediatric Cerebral Performance Category、Infant and Toddler Quality of Life Questionnaire (97-item full-length version) (<2 yr old)、Pediatric Quality of Life Inventory (≥2 yr old)、Child Post-traumatic Stress Disorder Symptom Scale (≥8 yr old and developmentally able)を使用して機能状態を評価した。
機能状態はベースラインからフォローアップにかけて20%悪化した。
機能状態の低下は治療群によって変わりなく、ベースラインで障害がある群の方がない群よりも多かった(27 vs. 18%; P < 0.001)。
治療群で健康関連ＱＯＬの全体スコアは差がなかった。外傷後ストレス障害のリスクスコアは30%に起こり、治療群で差はなかった。
＜感想＞
挿管中の小児をできるだけ覚醒させ、鎮静剤の投与を少なくしても、長期的な機能障害に差はなかったようです。
Rationale: 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.
Objectives: To compare postdischarge outcomes in children with acute respiratory failure cluster-randomized to a sedation protocol or usual care.
Methods: 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.
Measurements and Main Results: 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.
Conclusions: 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.