Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorYan Fuxia

About this trial

This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered school-aged children undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Children's Sleep Habits Questionnaire (CSHQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.

Eligibility criteria

Qualifiers

Age 0-36 months

Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.

Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score >48)

Disqualifiers

Preoperative use of sleep therapy-related medications

The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4

History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue

Emergency surgery or preoperative ICU admission

Trial design

Treatments tested in this trial

  • cognitive-behavioral intervention

Treatment groups

544 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yan Fuxia

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Sponsor institution