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Down Syndrome Autonomic Nervous System Induction Bradycardia (DANSIB)

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ClinicalTrials.gov Identifier: NCT05120531
Recruitment Status : Recruiting
First Posted : November 15, 2021
Last Update Posted : January 26, 2022
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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
Down Syndrome Bradycardia Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia

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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Finding the Contribution of the Autonomic Nervous System During Perioperative Events in Children With Down Syndrome
Actual Study Start Date : January 4, 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Group/Cohort 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.




Primary Outcome Measures :
  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%



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Ages Eligible for Study:   1 Month to 8 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study population will be children age 1 month to 8 years undergoing otolaryngologic surgery with anesthesia.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05120531


Contacts
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Contact: Jamie Sinton 5136364408 jamie.sinton@cchmc.org
Contact: Eun Ko 5136367860 eun.ko@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jamie Sinton, MD    513-636-4408      
Principal Investigator: Jamie Sinton, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jamie Sinton Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT05120531    
Other Study ID Numbers: 2021-0643
R21HL162572 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Down Syndrome
Bradycardia
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases