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

Not yet recruiting

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

• Registration Number: NCT06686550
• Lead Sponsor: Yan Fuxia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-31
• Status Verified: 2024-11
• Study Start: 2024-11-10
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-11-10
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 435

Inclusion Criteria

• Aged more than 28 days and less than 14 years old；
• Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.

Exclusion Criteria

• Emergency surgery;
• Combined with severe hepatic and renal dysfunction (with a diagnosis of acute or chronic renal insufficiency or requiring renal replacement therapy; with a diagnosis of acute or chronic hepatic insufficiency or requiring artificial liver treatment);
• Combined with non-cardiac malformations (adenoidal hypertrophy, tracheobronchial stenosis and ocular disorders);
• History of preoperative cerebral ischemia or haemorrhage;
• Refuse to sign the informed consent form or the child has poor compliance.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium	Postoperative 7 days

Secondary Outcome Measures

Name	Time	Method
The proportions of subtypes of postoperative delirium( hypoactive, hyperactive, and mixed).	Postoperative 7 days
Pain defined by the Face, Legs, Activity, Cry, and Consolability scale	Postoperative 7 days	The FLACC scale is a simple and effective tool used to assess pain in infants and non-verbal patients. It stands for Face, Legs, Activity, Cry, and Consolability. Each of these five items is scored on a scale of 0 to 2, with a higher score indicating a greater degree of pain. The total FLACC score, ranging from 0 to 10, provides a quick and reliable assessment of the patient's pain level.
The incidence of postoperative Acute kidney injury	Within postoperative 7 days.
Pulmonary complication	Postoperative 7 days
The incidence of postoperative Liver dysfunction	Postoperative 7 days
The duration of postoperative mechanical ventilation	From the end of the surgery to discharge from the hospital，up to 30 days.	The total hours needing mechanical ventilation support
The length of intensive care unit stay	From the end of the surgery to discharge from the hospital, up to 30 days.	The time spent in the intensive care unit.
The length of postoperative hospital stay	From the end of the surgery to the day of discharge from the hospital, up to 30 days..