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Completed

NCT Number: NCT05120531

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 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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Arrhythmias, Cardiac Bradycardia Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 month–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia

Other

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.

Primary outcomes

  1. Ambulatory feasibility of VU-AMS monitor on patients with Down Syndrome

    Time frame: 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.

  2. Ambulatory feasibility of VU-AMS monitor on patients without Down Syndrome

    Time frame: 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.

  3. Operating room feasibility of VU-AMS monitor on patients with Down Syndrome

    Time frame: 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

  4. Operating room feasibility of VU-AMS monitor on patients without Down Syndrome

    Time frame: 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

  5. Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients with Down Syndrome

    Time frame: 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%

  6. Autonomic data including pre-ejection period and respiratory sinus arrhythmia among patients without Down Syndrome

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: DANSIB

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2021
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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