NCT05120531

Down Syndrome Autonomic Nervous System Induction Bradycardia

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 195 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 1 Month – 8 Years
• Healthy volunteers: —

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.

Conditions

• Down Syndrome
• Bradycardia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-04
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2021-11-15
• Last updated: 2023-12-15

Locations

1 site across 1 country: United States