Down Syndrome Autonomic Nervous System Induction Bradycardia

Completed

• Conditions: Down Syndrome; Bradycardia
• Interventions: Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia

• Registration Number: NCT05120531
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

Children with Down syndrome (DS) often experience dangerously low heart rates on induction of anesthesia for routine procedures and this occurs at 10 times the rate of non-DS patients. Given that the cardiac output of children is heart rate dependent, bradycardia is especially perilous in this population.

Historically, individuals with DS were not expected to survive beyond childhood; consequently, correction of congenital anomalies, e.g. cardiac defects, was not frequently offered. Fortunately, today individuals with DS live into adulthood and surgical correction of anomalies is universally offered. Thus, increasing numbers of children with DS are exposed to anesthesia and at risk for this hemodynamic catastrophe. It is medically unacceptable and an autonomic nervous system mechanism will be sought.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-15
• Study Start: 2022-01-04
• Status Verified: 2023-12
• Primary Completion: 2023-12-12
• Study Completion: 2023-12-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• Patients who are overtly healthy as determined by medical evaluation including lack of diagnosis of Down Syndrome and children with Down Syndrome

Exclusion Criteria

1. Contraindication to adhesive placement, eg, epidermolysis bullosa
2. Patient or parent refusal
3. Opioids
4. Heart rate altering therapy such as beta blockers
5. During the study period, participants will abstain from ingesting caffeine- or xanthine-containing products (eg, coffee, tea, cola drinks, and chocolate) for [6 hours] before the start of the anesthetic.
6. Participants will be assumed not to be using tobacco or alcohol during the study period due to their young age.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Down Syndrome patients undergoing otolaryngologic surgery with anesthesia	Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia	-
Non-Down Syndrome patients undergoing otolaryngologic surgery with anesthesia	Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia	-

Primary Outcome Measures

Name	Time	Method
Ambulatory feasibility of VU-AMS monitor on patients without Down Syndrome	Immediately upon entry into Same Day Surgery patient room	Subjects will be observed for monitor use coming to the hospital for surgery. The two outcomes will be binary: wearing the device or not. We anticipate that 50% of subjects will be wearing the VU-AMS monitor on entry to the hospital on the day of surgery.
Operating room feasibility of VU-AMS monitor on patients with Down Syndrome	Immediately prior to mask induction with sevoflurane	Subjects will be observed for monitor use throughout surgery. We anticipate that 80% of subjects will wear the VU-AMS in the operating room
Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients with Down Syndrome	Beginning at time of bradycardia and continuing for the next 300 seconds.	Among subjects who become bradycardic with induction of anesthesia, we expect that the pre-ejection period will increase by 20%
Ambulatory feasibility of VU-AMS monitor on patients with Down Syndrome	Immediately upon entry into Same Day Surgery patient room	Subjects will be observed for monitor use coming to the hospital for surgery. The two outcomes will be binary: wearing the device or not. We anticipate that 50% of subjects will be wearing the VU-AMS monitor on entry to the hospital on the day of surgery.
Operating room feasibility of VU-AMS monitor on patients without Down Syndrome	Immediately prior to mask induction with sevoflurane	Subjects will be observed for monitor use throughout surgery. We anticipate that 80% of subjects will wear the VU-AMS in the operating room
Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients without Down Syndrome	Beginning at time of bradycardia and continuing for the next 300 seconds.	Among subjects who become bradycardic with induction of anesthesia, we expect that the pre-ejection period will increase by 20%

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States