Congenital Heart Disease (CHD), Delirium - Postoperative, Sleep Problems
Conditions
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.
Interventions
This is a observational study and there is no intervention.
Sponsors
Yan Fuxia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
28 Days to 14 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of postoperative delirium | Postoperative 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative Acute kidney injury | Within 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 total hours needing mechanical ventilation support |
| The length of intensive care unit stay | From the end of the surgery to discharge from the hospital, up to 30 days. | The time spent in the intensive care unit. |
| The length of postoperative hospital stay | From the end of the surgery to the day of discharge from the hospital, up to 30 days.. | — |
| 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 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. |
| Pulmonary complication | Postoperative 7 days | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concentration of plasma inflammatory factors. | Before surgery and 24 hours after surgery | The inflammatory cytokines include IL-6，TNF-α，IL-1β，IFN-γ，IL-17, C-reactive protein. |
| Types and total dosages of sedative and analgesic medications | From the start of the surgery to discharge from the hospital, up to 30 days. | — |
| Concentration of plasma intestinal injury markers | Before surgery and 24 hours after surgery | Intestinal fatty acid binding protein, Zonulin, Lipopolysaccharide and so on. |
| Concentration of plasma blood-brain barrier injury markers | Before surgery and 24 hours after surgery | — |
Contacts
Primary ContactFuxia Yan
Outcome results
None listed