DANSIB: Down Syndrome Autonomic Nervous System Induction Bradycardia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Down Syndrome patients undergoing otolaryngologic surgery with anesthesia
|
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.
|
| Non-Down Syndrome patients undergoing otolaryngologic surgery with anesthesia
|
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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
- 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 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%
- 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%
Eligibility Criteria
Criteria
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:
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Contraindication to adhesive placement, eg, epidermolysis bullosa
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Patient or parent refusal
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Opioids
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Heart rate altering therapy such as beta blockers
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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.
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Participants will be assumed not to be using tobacco or alcohol during the study period due to their young age.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
- National Institutes of Health (NIH)
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Jamie Sinton, Children's Hospital Medical Center, Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-0643
- R21HL162572