Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age28-14
SponsorYan Fuxia
About this trial
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
Qualifiers
Aged more than 28 days and less than 14 years old；
Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- This is a observational study and there is no intervention.
Treatment groups
435 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Yan Fuxia
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution
Source ClinicalTrials.gov