Down Syndrome Autonomic Nervous System Induction Bradycardia

Down Syndrome Clinical Trial

— DANSIB  

Official title:

Finding the Contribution of the Autonomic Nervous System During Perioperative Events in Children With Down Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120531
• Other study ID #: 2021-0643
• Secondary ID: R21HL162572
• Status: Completed
• Start date: January 4, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: December 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 2023
• Gender: All
• Age group: 1 Month to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Down Syndrome
• Syndrome

Intervention

Other:
• Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia
Use of an Ambulatory Monitoring System from Vuije University (VU-AMS) to record autonomic and cardiovascular activity of patients undergoing otolaryngologic surgery with anesthesia. This monitoring device will provide data of ANS activity and normoxic bradycardia among patients with Down Syndrome. This data will be compared to data from patients without Down Syndrome.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory feasibility of VU-AMS monitor on patients with Down Syndrome	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.	Immediately upon entry into Same Day Surgery patient room
Primary	Ambulatory feasibility of VU-AMS monitor on patients without Down Syndrome	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.	Immediately upon entry into Same Day Surgery patient room
Primary	Operating room feasibility of VU-AMS monitor on patients with Down Syndrome	Subjects will be observed for monitor use throughout surgery. We anticipate that 80% of subjects will wear the VU-AMS in the operating room	Immediately prior to mask induction with sevoflurane
Primary	Operating room feasibility of VU-AMS monitor on patients without Down Syndrome	Subjects will be observed for monitor use throughout surgery. We anticipate that 80% of subjects will wear the VU-AMS in the operating room	Immediately prior to mask induction with sevoflurane
Primary	Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients with Down Syndrome	Among subjects who become bradycardic with induction of anesthesia, we expect that the pre-ejection period will increase by 20%	Beginning at time of bradycardia and continuing for the next 300 seconds.
Primary	Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients without Down Syndrome	Among subjects who become bradycardic with induction of anesthesia, we expect that the pre-ejection period will increase by 20%	Beginning at time of bradycardia and continuing for the next 300 seconds.