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

Yan Fuxia

Status: Not yet enrolling

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

Treatments: Other: This is a observational study and there is no intervention.

Study type: Observational

Funder types: Other

Identifiers

NCT06686550

2024-2414

Details and patient eligibility

About

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.

Enrollment: 435 estimated patients

Sex: All

Ages: 28 days to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

435 participants in 1 patient group

Children scheduled to undergo elective congenital heart disease repair surgery with CPB

Treatment:

Other: This is a observational study and there is no intervention.