Clinical trial NCT06686550: Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery
Official title: The Impact of Preoperative Sleep Disorders on the Incidence of Postoperative Delirium in Children Undergoing Congenital Heart Surgery: A Prospective, Observational, Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Delirium - Postoperative
Sleep Problems
Congenital Heart Disease (CHD)
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 435
Sex: ALL
Minimum age (years): 28
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: The incidence of postoperative delirium
timeFrame: Postoperative 7 days
Secondary outcomes:
measure: The proportions of subtypes of postoperative delirium( hypoactive, hyperactive, and mixed).
timeFrame: Postoperative 7 days
measure: Pain defined by the Face, Legs, Activity, Cry, and Consolability scale
timeFrame: Postoperative 7 days
measure: The incidence of postoperative Acute kidney injury
timeFrame: Within postoperative 7 days.
measure: Pulmonary complication
timeFrame: Postoperative 7 days
measure: The incidence of postoperative Liver dysfunction
timeFrame: Postoperative 7 days
measure: The duration of postoperative mechanical ventilation
timeFrame: From the end of the surgery to discharge from the hospital，up to 30 days.
measure: The length of intensive care unit stay
timeFrame: From the end of the surgery to discharge from the hospital, up to 30 days.
measure: The length of postoperative hospital stay
timeFrame: From the end of the surgery to the day of discharge from the hospital, up to 30 days..
Other outcomes:
measure: Concentration of plasma intestinal injury markers
timeFrame: Before surgery and 24 hours after surgery
measure: Concentration of plasma blood-brain barrier injury markers
timeFrame: Before surgery and 24 hours after surgery
measure: Concentration of plasma inflammatory factors.
timeFrame: Before surgery and 24 hours after surgery
measure: Types and total dosages of sedative and analgesic medications
timeFrame: From the start of the surgery to discharge from the hospital, up to 30 days.
Locations:
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