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

November 11, 2024 updated by: Yan Fuxia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
435

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Children scheduled to undergo elective congenital heart disease repair surgery with CPB
Other: This is a observational study and there is no intervention.
This is a observational study and there is no intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The incidence of postoperative delirium
Time Frame: Postoperative 7 days
Postoperative 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportions of subtypes of postoperative delirium( hypoactive, hyperactive, and mixed).
Time Frame: Postoperative 7 days
Postoperative 7 days
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.
Postoperative 7 days
The incidence of postoperative Acute kidney injury
Time Frame: Within postoperative 7 days.
Within postoperative 7 days.
Pulmonary complication
Time Frame: Postoperative 7 days
Postoperative 7 days
The incidence of postoperative Liver dysfunction
Time Frame: Postoperative 7 days
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 total hours needing mechanical ventilation support
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 time spent in the intensive care unit.
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..
From the end of the surgery to the day of discharge from the hospital, up to 30 days..

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Before surgery and 24 hours after surgery
Concentration of plasma blood-brain barrier injury markers
Time Frame: Before surgery and 24 hours after surgery
Before surgery and 24 hours after surgery
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.
Before surgery and 24 hours after surgery
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.
From the start of the surgery to discharge from the hospital, up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yan Fuxia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-2414

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings