Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05120531
Other study ID # 2021-0643
Secondary ID R21HL162572
Status Completed
Phase
First received
Last updated
Start date January 4, 2022
Est. completion date December 12, 2023

Study information

Verified date December 2023
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 195
Est. completion date December 12, 2023
Est. primary completion date December 12, 2023
Accepts healthy volunteers
Gender All
Age group 1 Month to 8 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (3)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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.
Primary 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.
See also
  Status Clinical Trial Phase
Recruiting NCT04854122 - Blood Flow Regulation in Individuals With Down Syndrome - Training Study N/A
Completed NCT04020302 - Self-Monitoring Shopping Intervention N/A
Recruiting NCT01950624 - DS-Connect {TM}: The Down Syndrome Registry
Completed NCT04751136 - the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome Phase 2
Completed NCT04767412 - Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial N/A
Not yet recruiting NCT04037579 - Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
Completed NCT04536506 - Bobath and Vojta Therapy for DS N/A
Recruiting NCT05528549 - Blood Flow and Blood Pressure Investigation in Down Syndrome Phase 3
Completed NCT02882698 - Performance Analysis in Down Syndrome on Mobile Phone N/A
Completed NCT01791725 - A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia Phase 2
Unknown status NCT01975545 - Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21 Phase 2
Completed NCT01808508 - Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome N/A
Terminated NCT00754052 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 Phase 3
Terminated NCT00754013 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10 Phase 3
Completed NCT01256112 - Parent Supported Weight Reduction in Down Syndrome N/A
Completed NCT01313325 - Hippotherapy to Improve the Balance of Children With Movement Disorders N/A
Completed NCT01594346 - Multicenter Vitamin E Trial in Aging Persons With Down Syndrome Phase 3
Completed NCT05343468 - Life Skills Improved in Children With Down Syndrome After Using Assistive Technology N/A
Suspended NCT05755464 - Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
Recruiting NCT04022460 - Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)