NCT06686550

Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery

The Impact of Preoperative Sleep Disorders on the Incidence of Postoperative Delirium in Children Undergoing Congenital Heart Surgery: A Prospective, Observational, Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 435 (estimated)
• Sponsor: Yan Fuxia · Academic / Other
• Sex: All
• Age: 28 Days – 14 Years
• Healthy volunteers: Not accepted

Summary

The investigators are going to conduct a prospective observational cohort study in pediatric patients aged 28 days to 14 years old scheduled for elective cardiac surgery with cardiopulmonary bypass. The primary purpose of this study is to explore the effect of preoperative sleep disturbance on the incidence of postoperative delirium. Sleep status will be assessed using the Brief Infant Sleep Questionnaire(BISQ) and Children's Sleep Habits Questionnaire (CSHQ), and postoperative delirium status will be evaluated by Cornell assessment of pediatric delirium(CAPD). During the peri-operative period, children will wear actigraphs to record their sleep parameters.

Conditions

• Delirium - Postoperative
• Sleep Problems
• Congenital Heart Disease (CHD)

Interventions

Type	Name	Description
OTHER	This is a observational study and there is no intervention.	This is a observational study and there is no intervention.

Timeline

• Start date: 2024-11-10
• Primary completion: 2025-11-10
• Completion: 2026-06-15
• First posted: 2024-11-13
• Last updated: 2024-11-13