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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Heart Disease (CHD); Sleep Problems; Delirium - Postoperative
• Intervention / Treatment: Other: This is a observational study and there is no intervention.

• Study Type: Observational
• Enrollment (Estimated): 435

Contacts and Locations

• Study Contact: Name: Fuxia Yan; Phone Number: 01088396628; Email: yanfuxia@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pediatric patients aged more than 28 days and less than 14 years old who are scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children scheduled to undergo elective congenital heart disease repair surgery with CPB	Other: This is a observational study and there is no intervention.; This is a observational study and there is no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of postoperative delirium	Postoperative 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Postoperative 7 days
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	The total hours needing mechanical ventilation support	From the end of the surgery to discharge from the hospital，up to 30 days.
The length of intensive care unit stay	The time spent in the intensive care unit.	From the end of the surgery to discharge from the hospital, up to 30 days.
The length of postoperative hospital stay		From the end of the surgery to the day of discharge from the hospital, up to 30 days..

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of plasma intestinal injury markers	Intestinal fatty acid binding protein, Zonulin, Lipopolysaccharide and so on.	Before surgery and 24 hours after surgery
Concentration of plasma blood-brain barrier injury markers		Before surgery and 24 hours after surgery
Concentration of plasma inflammatory factors.	The inflammatory cytokines include IL-6，TNF-α，IL-1β，IFN-γ，IL-17, C-reactive protein.	Before surgery and 24 hours after surgery
Types and total dosages of sedative and analgesic medications		From the start of the surgery to discharge from the hospital, up to 30 days.

Collaborators and Investigators

• Sponsor: Yan Fuxia

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2024
• Primary Completion (Estimated): November 10, 2025
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: October 31, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Estimated): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Congenital Abnormalities; Cardiovascular Abnormalities; Emergence Delirium; Delirium; Dyssomnias; Parasomnias; Heart Diseases; Heart Defects, Congenital; Sleep Wake Disorders
• Other Study ID Numbers: 2024-2414

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No