Delirium - PostoperativeNCT06686550
Preoperative Sleep Disorders and Postoperative Delirium in Children Undergoing Congenital Heart Surgery
An observational study of Delirium - Postoperative and Sleep Problems, run by Yan Fuxia.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 days to 14 years
- Conditions the study is for
- Delirium - Postoperative, Sleep Problems, Congenital Heart Disease (CHD)
- How many people
- 435 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2024to 15 Jun 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 14 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Aged more than 28 days and less than 14 years old；
- Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- This is a observational study and there is no intervention.
- Medical subject headings
- Emergence Delirium, Parasomnias, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a observational study and there is no intervention.Other
This is a observational study and there is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Children scheduled to undergo elective congenital heart disease repair surgery with CPB | Not described Receives: Other: This is a observational study and there is no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium
Measured: Postoperative 7 days
Secondary outcomes (8)
The proportions of subtypes of postoperative delirium( hypoactive, hyperactive, and mixed).
Measured: Postoperative 7 days
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.
Measured: Postoperative 7 days
The incidence of postoperative Acute kidney injury
Measured: Within postoperative 7 days.
Pulmonary complication
Measured: Postoperative 7 days
The incidence of postoperative Liver dysfunction
Measured: Postoperative 7 days
The duration of postoperative mechanical ventilation
The total hours needing mechanical ventilation support
Measured: From the end of the surgery to discharge from the hospital，up to 30 days.
The length of intensive care unit stay
The time spent in the intensive care unit.
Measured: From the end of the surgery to discharge from the hospital, up to 30 days.
The length of postoperative hospital stay
Measured: From the end of the surgery to the day of discharge from the hospital, up to 30 days..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start10 Nov 2024 (estimated)
- Primary completion10 Nov 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium - PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 435 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yan Fuxia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Fuxia, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686550
- Sponsor's protocol ID
- 2024-2414
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06686550
- Acronym / sponsor ID
- 2024-2414
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 435 participants (estimated)
- Lead sponsor
- Yan FuxiaUniversity, hospital or other
- Study start
- 10 Nov 2024 (estimated)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 13 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children scheduled to undergo elective congenital heart disease repair surgery with CPB | – | Other: This is a observational study and there is no intervention. |
Who may qualify
- Ages
- 28 days to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Aged more than 28 days and less than 14 years old；
- Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a observational study and there is no intervention.This is a observational study and there is no intervention. | Other | Children scheduled to undergo elective congenital heart disease repair surgery with CPB |
Primary outcome
The incidence of postoperative delirium
Time frame: Postoperative 7 days
8 secondary outcomes
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..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium - Postoperative and Sleep Problems, run by Yan Fuxia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fuxia Yan (01088396628, yanfuxia@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium (time frame: Postoperative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.