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Down Syndrome Autonomic Nervous System Induction Bradycardia

NCT05120531 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 195

Last updated 2023-12-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Jamie Sinton · Children's Hospital Medical Center, Cincinnati

Eligibility

Min Age
1 Month
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2023-12-12
Completion
2023-12-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05120531 on ClinicalTrials.gov