Down Syndrome Autonomic Nervous System Induction Bradycardia

Study Overview
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Brief Summary
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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.

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

Conditions
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Down Syndrome, Bradycardia

Intervention / Treatment
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* Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia


Participation Criteria
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Eligibility Criteria
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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: Contraindication to adhesive placement, eg, epidermolysis bullosa Patient or parent refusal Opioids Heart rate altering therapy such as beta blockers 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. Participants will be assumed not to be using tobacco or alcohol during the study period due to their young age.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Down Syndrome patients undergoing otolaryngologic surgery with anesthesia<br> | Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia<br>* 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.<br>|
| Non-Down Syndrome patients undergoing otolaryngologic surgery with anesthesia<br> | Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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. | 
| 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. |