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NCT05120531 · ClinicalTrials.gov registry record
Down Syndrome Autonomic Nervous System Induction Bradycardia
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- 195
- Enrollment target
NCT05120531: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT05120531 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 195 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05120531 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- 195 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- OTHER Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 195 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2023-12-12 |
What the finished NCT05120531 record still lists
NCT05120531 is an observational study that tracks outcomes without assigning an intervention. The registered 195 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia is the first listed.
NCT05120531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05120531 about?
NCT05120531 is a clinical study titled "Down Syndrome Autonomic Nervous System Induction Bradycardia". 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 popul...
What is the current status of trial NCT05120531?
This trial is currently completed. The enrollment target is 195 participants. The study started on 2022-01-04. Estimated completion is 2023-12-12.
What interventions are being tested in trial NCT05120531?
The interventions under investigation include: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia (OTHER).
Who is sponsoring clinical trial NCT05120531?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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