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

NCT06686550 | Not Yet Recruiting

• 1 other identifier: 2024-2414
• Study Type: observational
• Target: 435
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• The incidence of postoperative delirium

  Postoperative 7 days

Secondary Outcomes (8)

• 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 incidence of postoperative Acute kidney injury

  Within postoperative 7 days.

• Pulmonary complication

  Postoperative 7 days

• The incidence of postoperative Liver dysfunction

  Postoperative 7 days

Other Outcomes (4)

• Concentration of plasma intestinal injury markers

  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.

  Before surgery and 24 hours after surgery

Study Arms (1)

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

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

Interventions

This is a observational study and there is no intervention. OTHER

This is a observational study and there is no intervention.

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

Eligibility Criteria

• Age: 28 Days - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yan Fuxia: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Emergence Delirium; Parasomnias; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Fuxia Yan

CONTACT

01088396628; yanfuxia@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chinese Academy of Medical Sciences, Fuwai Hospital

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 13, 2024
• Study Start: November 10, 2024
• Primary Completion: November 10, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: November 13, 2024

Record last verified: 2024-11