Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorYan Fuxia
About this trial
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 0-3 years
Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.
Children with sleep disorders who are screened by the Brief Infant Sleep Questionnaire-Revised short form (BISQ-R SF).
Disqualifiers
Infants and toddlers who have taken any relevant preoperative treatment for sleep problems
The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4.
Preoperative history of cerebral ischemia and hypoxia, developmental disorders such as autism spectrum disorders, etc.
Presence of any other preoperative acute or chronic medical condition (mechanical ventilation support, history of asphyxia rescue, severe hepatic or renal dysfunction, or comorbidities with other non-cardiac malformations)
Trial design
Design model
Parallel
Treatments tested in this trial
Message-based bedtime routine
BehavioralThe intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message.
sleep hygiene education
BehavioralSleep hygiene education includes sleep environment, sleeping location, regular sleep schedule, bedtime routines, sleeping methods, and sleeping posture.
Treatment groups
452 Participants
are divided into 2 treatment groupsGroup A: Message-based bedtime routine groupExperimental treatment 1 intervention
Group B: Sleep hygiene education groupOther 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of postoperative delirium
Time frame
Postoperative 7 daysSecondary outcomes
1
Mechanistic endpoint: Concentration of plasma S-100β protein
S-100β protein was used as a surrogate biomarker for the disruption of the blood-brain barrier.
Time frame
Before surgery, at the end of surgery and 24 hours after surgery2
Postoperative sleep quality
Postoperative sleep quality was assessed using the Actigraph model wGT3X-BT body movement recorder. The Actigraph model wGT3X-BT was worn from the time of admission to 7 days after surgery in order to assess the sleep quality of the subjects.
Time frame
Postoperative 7 days or before discharge3
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.
Time frame
Postoperative 7 days4
The incidence of postoperative Acute kidney injury
Time frame
Within postoperative 7 daysOther outcomes
1
Long-term Sleep quality score
guardians scored sleep quality 1-5 using a sleep diary
Time frame
30 days, 6 months, 1 year after discharge2
Readmission rate
the rate at which a patient is readmitted to the hospital for the same or a different health problem within 30 days/six months/1 year after discharge
Time frame
30 days/6 months/1 year after discharge3
1-Year Mortality and Survival
The rate at which patients die and survive within 1 year of discharge from the hospital.
Time frame
1 year after dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yan Fuxia
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution
Source ClinicalTrials.gov