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
This trial does not accept healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
This is a observational study and there is no intervention.
Other interventionThis is a observational study and there is no intervention.
Treatment groups
435 Participants
are divided into 1 treatment groupGroup A: Children scheduled to undergo elective congenital heart disease repair surgery with CPB1 intervention
Trial outcomes
Primary outcomes
1
The incidence of postoperative delirium
Time frame
Postoperative 7 daysSecondary outcomes
1
The proportions of subtypes of postoperative delirium( hypoactive, hyperactive, and mixed).
Time frame
Postoperative 7 days2
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.
Time frame
Postoperative 7 days3
The incidence of postoperative Acute kidney injury
Time frame
Within postoperative 7 days.4
Pulmonary complication
Time frame
Postoperative 7 daysOther outcomes
1
Concentration of plasma intestinal injury markers
Intestinal fatty acid binding protein, Zonulin, Lipopolysaccharide and so on.
Time frame
Before surgery and 24 hours after surgery2
Concentration of plasma blood-brain barrier injury markers
Time frame
Before surgery and 24 hours after surgery3
Concentration of plasma inflammatory factors.
The inflammatory cytokines include IL-6，TNF-α，IL-1β，IFN-γ，IL-17, C-reactive protein.
Time frame
Before surgery and 24 hours after surgery4
Types and total dosages of sedative and analgesic medications
Time frame
From the start of the surgery to discharge from the hospital, up to 30 days.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yan Fuxia
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: