Clinical trial NCT05120531: Down Syndrome Autonomic Nervous System Induction Bradycardia
Official title: Finding the Contribution of the Autonomic Nervous System During Perioperative Events in Children With Down Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Bradycardia
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-11-15
Enrollment: 195
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be children age 1 month to 8 years undergoing otolaryngologic surgery with anesthesia.

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.


Eligibility 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:

1. Contraindication to adhesive placement, eg, epidermolysis bullosa
2. Patient or parent refusal
3. Opioids
4. Heart rate altering therapy such as beta blockers
5. 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.
6. Participants will be assumed not to be using tobacco or alcohol during the study period due to their young age.

Primary outcomes:
measure: Ambulatory feasibility of VU-AMS monitor on patients with Down Syndrome
timeFrame: Immediately upon entry into Same Day Surgery patient room
measure: Ambulatory feasibility of VU-AMS monitor on patients without Down Syndrome
timeFrame: Immediately upon entry into Same Day Surgery patient room
measure: Operating room feasibility of VU-AMS monitor on patients with Down Syndrome
timeFrame: Immediately prior to mask induction with sevoflurane
measure: Operating room feasibility of VU-AMS monitor on patients without Down Syndrome
timeFrame: Immediately prior to mask induction with sevoflurane
measure: Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients with Down Syndrome
timeFrame: Beginning at time of bradycardia and continuing for the next 300 seconds.
measure: Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients without Down Syndrome
timeFrame: Beginning at time of bradycardia and continuing for the next 300 seconds.
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jamie Sinton
role: PRINCIPAL_INVESTIGATOR
References: