Long-Term Outcomes after Protocolized Sedation versus Usual Care in Ventilated Pediatric Patients

Abstract

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. Clinical trial registered with www.clinicaltrials.gov (NCT00814099).

Keywords: functional status; health care outcomes; health-related quality of life; post-traumatic stress disorder; respiratory failure.

Figure 1.

Flow diagram of study patients enrolled in the RESTORE (Randomized Evaluation of Sedation Titration for Respiratory Failure) trial, including follow-up. *Follow-up rate: 1,073/1,360 = 79%. ^†Parents/guardians provided health-related quality of life data via Infant and Toddler Quality of Life Questionnaire (ITQOL) or Pediatric Quality of Life Inventory (PedsQL). For ITQOL, parents/guardians provided data for 53 patients 6 years of age or older; these data were analyzed separately, as the instrument is validated for children younger than 6 years of age. For PedsQL, parents/guardians provided incomplete data for five patients, so that the PedsQL could not be scored. SP = sedation protocol; UC = usual care.