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Not yet recruiting NCT06686550

Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery

— Observational Delirium - Postoperative Sleep Problems Congenital Heart Disease (CHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: This is a observational study and there is no intervention..
Who it may be relevant to
Registry conditions: Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD). Basic parameters: 28 Days — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Other This is a observational study and there is no intervention.
    This is a observational study and there is no intervention.

Primary outcome measures

  • The incidence of postoperative delirium [Time frame: Postoperative 7 days]
Secondary outcome measures (8)
  • The proportions of subtypes of postoperative delirium( hypoactive, hyperactive, and mixed). [Time frame: Postoperative 7 days]
  • Pain defined by the Face, Legs, Activity, Cry, and Consolability scale [Time frame: Postoperative 7 days]
  • The incidence of postoperative Acute kidney injury [Time frame: Within postoperative 7 days.]
  • Pulmonary complication [Time frame: Postoperative 7 days]
  • The incidence of postoperative Liver dysfunction [Time frame: Postoperative 7 days]
  • The duration of postoperative mechanical ventilation [Time frame: From the end of the surgery to discharge from the hospital，up to 30 days.]
  • The length of intensive care unit stay [Time frame: From the end of the surgery to discharge from the hospital, up to 30 days.]
  • The length of postoperative hospital stay [Time frame: From the end of the surgery to the day of discharge from the hospital, up to 30 days..]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06686550 · 2024-2414

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗