Down SyndromeDANSIBNCT05120531
Down Syndrome Autonomic Nervous System Induction Bradycardia
An observational study of Down Syndrome and Bradycardia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 month to 8 years
- Conditions the study is for
- Down Syndrome, Bradycardia
- What is being tested?
- Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 12 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 8 years
- All sexes
- Child
Study population: The study population will be children age 1 month to 8 years undergoing otolaryngologic surgery with anesthesia.
Who may be able to join
- Patients who are overtly healthy as determined by medical evaluation including lack of diagnosis of Down Syndrome and children with Down Syndrome
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Finding the Contribution of the Autonomic Nervous System During Perioperative Events in Children With Down Syndrome
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.
- Conditions
- Down Syndrome, Bradycardia
- Being tested
- Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia
- Medical subject headings
- Down Syndrome, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring patients undergoing surgery to look for association between ANS activity and bradycardiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Down Syndrome patients undergoing otolaryngologic surgery with anesthesia | Not described Receives: Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia | |
| Non-Down Syndrome patients undergoing otolaryngologic surgery with anesthesia | Not described Receives: Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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%
Measured: 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%
Measured: Beginning at time of bradycardia and continuing for the next 300 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start4 Jan 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jamie Sinton, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120531
- Sponsor's protocol ID
- 2021-0643
- Other IDs
- R21HL162572
- Acronym
- DANSIB
- Status last verified
- Dec 2023
- First submitted
- 3 Nov 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding the Contribution of the Autonomic Nervous System During Perioperative Events in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT05120531
- Acronym / sponsor ID
- DANSIB / 2021-0643
- Conditions
- Down Syndrome, Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Down Syndrome patients undergoing otolaryngologic surgery with anesthesia | – | Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia |
| Non-Down Syndrome patients undergoing otolaryngologic surgery with anesthesia | – | Other: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia |
Who may qualify
- Ages
- 1 month to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- The study population will be children age 1 month to 8 years undergoing otolaryngologic surgery with anesthesia.
Key inclusion criteria (1 listed)
- Patients who are overtly healthy as determined by medical evaluation including lack of diagnosis of Down Syndrome and children with Down Syndrome
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring patients undergoing surgery to look for association between ANS activity and bradycardiaUse 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. | Other | Down Syndrome patients undergoing otolaryngologic surgery with anesthesia, Non-Down Syndrome patients undergoing otolaryngologic surgery with anesthesia |
Primary outcome
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.
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.
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
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
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%
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%
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
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Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Sinton principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome and Bradycardia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory feasibility of VU-AMS monitor on patients with Down Syndrome (time frame: Immediately upon entry into Same Day Surgery patient room). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.