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NCT Number: NCT06686550

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

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.

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Key information

Conditions

Delirium - Postoperative Cardiovascular Abnormalities Cardiovascular Diseases Confusion Congenital Abnormalities Congenital Heart Disease (CHD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Delirium Emergence Delirium Heart Defects, Congenital Heart Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Sleep Problems Sleep Wake Disorders

Age range

28 day–14 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

This is a observational study and there is no intervention.

Other

This is a observational study and there is no intervention.

Primary outcomes

  1. The incidence of postoperative delirium

    Time frame: Postoperative 7 days

Secondary outcomes

  1. The proportions of subtypes of postoperative delirium( hypoactive, hyperactive, and mixed).

    Time frame: Postoperative 7 days

  2. Pain defined by the Face, Legs, Activity, Cry, and Consolability scale

    Time frame: 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.

  3. The incidence of postoperative Acute kidney injury

    Time frame: Within postoperative 7 days.

  4. Pulmonary complication

    Time frame: Postoperative 7 days

  5. The incidence of postoperative Liver dysfunction

    Time frame: Postoperative 7 days

  6. The duration of postoperative mechanical ventilation

    Time frame: From the end of the surgery to discharge from the hospital，up to 30 days.

    The total hours needing mechanical ventilation support

  7. 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 time spent in the intensive care unit.

  8. 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..

Other outcomes

  1. Concentration of plasma intestinal injury markers

    Time frame: Before surgery and 24 hours after surgery

    Intestinal fatty acid binding protein, Zonulin, Lipopolysaccharide and so on.

  2. Concentration of plasma blood-brain barrier injury markers

    Time frame: Before surgery and 24 hours after surgery

  3. Concentration of plasma inflammatory factors.

    Time frame: Before surgery and 24 hours after surgery

    The inflammatory cytokines include IL-6，TNF-α，IL-1β，IFN-γ，IL-17, C-reactive protein.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fuxia Yan

CONTACT

[email protected]

01088396628

Sponsors and collaborators

Lead sponsor

Yan Fuxia

Other

Registry information

Official study title

The Impact of Preoperative Sleep Disorders on the Incidence of Postoperative Delirium in Children Undergoing Congenital Heart Surgery: A Prospective, Observational, Cohort Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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