The Impact of Preoperative Sleep Disorders on the Incidence of Postoperative Delirium in Children Undergoing Congenital Heart Surgery: A Prospective, Observational, Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 435
- Primary Endpoint
- The incidence of postoperative delirium
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 28 Days to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
The incidence of postoperative delirium
Time Frame: Postoperative 7 days
Secondary Outcomes
- 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)
- The duration of postoperative mechanical ventilation(From the end of the surgery to discharge from the hospital，up to 30 days.)
- The length of intensive care unit stay(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..)
Investigators
Yan Fuxia
Chinese Academy of Medical Sciences, Fuwai Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital