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

NCT ID: NCT06686550

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 435 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2026-06-15

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

This is a observational study and there is no intervention.

Intervention Type: OTHER

This is a observational study and there is no intervention.

Interventions

This is a observational study and there is no intervention.

This is a observational study and there is no intervention.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yan Fuxia

OTHER

Sponsor Role: lead

Responsible Party

Yan Fuxia

Chinese Academy of Medical Sciences, Fuwai Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Fuxia Yan

Role: CONTACT

yanfuxia@sina.com

01088396628

Other Identifiers

2024-2414

Identifier Type: -

Identifier Source: org_study_id