Congenital Heart DiseaseNCT05526768
Evaluation of VITLS Compared to Traditional Inpatient Monitoring in Cardiac Shunt-Dependent Children
A study testing VITLS Device in people with Congenital Heart Disease and Desaturation of Blood, run by Baylor College of Medicine at 1 site in United States.
Trial summary
We are seeing how well a remote monitoring device that looks like a sticker placed on the chest, under the arm can monitor a child's vital signs including oxygen levels compared to the way that we usually get these measurements. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Congenital Heart Disease, Desaturation of Blood
- What is being tested?
- VITLS Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2022to 10 May 2023
- Phase
- Interventional
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cardiac shunt-dependent patients aged 0-1 year old located in the Texas Children's Hospital Cardiac Intensive Care Unit (CVICU)
Who cannot join
- Presence of any implanted metal or electronic medical devices present in the chest (i.e. pace makers)
- Allergy to medical grade (latexfree) adhesive
- Any congenital or acquired desquamating skin condition (e.g., staphylococcal scalded skin syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Any other medical condition which, in the opinion of the Investigator, could affect the participant's health during trial participation or could compromise his/her ability to participate in the trial.
- In the opinion of the investigator, the participant and his/her parent(s) or legal guardian(s) is not reliable for participation in the trial.
- Parental language of comfort is not English or Spanish.
- Parents do not consent for study inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Novel Remote Vital Sign Monitor Compared to Traditional Inpatient Monitoring in Cardiac Shunt-Dependent Children
We are seeing how well a remote monitoring device that looks like a sticker placed on the chest, under the arm can monitor a child's vital signs including oxygen levels compared to the way that we usually get these measurements. The goal of this study is to see if the new sticker can be used for monitoring patients with cardiac shunt dependent heart conditions from home once they are discharged home. Participating children will be monitored for 6-72 hours with the new sticker in addition to his/her usual hospital monitors so the new sticker device can be compared to our hospital monitors.
Read the detailed description
Children with congenital heart disease who are cardiac shunt dependent are at increased risk for physiologic decompensation compared to non-shunt dependent children. This can lead to prolonged hospitalizations to facilitate careful vital sign monitoring to detect signs of deterioration early. While home monitoring programs have shown promise in this population, there is currently a shortage of pediatric specific remote monitoring devices that seamlessly provide vital sign results to caregivers and the healthcare team.
Over the past few years, home monitoring programs utilizing portable pulse oximetry to monitor oxygen saturation at home have reported improved survival in infants with single ventricle (cardiac shunt dependent) heart disease. Monitoring vital signs in cardiac shunt-dependent children presents challenges as most pulse oximeters are designed to monitor saturation levels greater than 85% SpO2 and shunt dependent children have baseline saturations closer to 75-85% SpO2. Additionally, traditional pulse oximetry probes are connected to a stationary monitor by leads of varying lengths. Children can easily remove these leads, thereby requiring frequent repositioning of the pulse oximeter. Additional limitations to current technology include inaccurate measurements due to motion artifact, need for frequent probe changes, parental requirement to log and interpret results, and the machines' lack of recording ability. An ideal monitor would be one that has continuous monitoring and recording features and provides feedback to the health care team in real time.
This study aims to evaluate a potential solution to some of the problems faced in home monitoring of cardiac shunt-dependent children. The proposed study device continuously measures pulse oximetry, heart rate, respiratory rate and temperature via a wireless probe that is placed on the child's chest. The device wirelessly transmits and stores the vital sign data continuously and can be accessed by authorized medical providers and the patient's caregivers at all times. The goal of this pilot study is to measure how the study device performs in comparison to standard-of-care hospital monitoring in the patients of interest.
- Conditions
- Congenital Heart Disease, Desaturation of Blood
- Being tested
- VITLS Device
- Keywords
- remote monitoring, pulse oximeter, cardiac shunt dependent, Tego, VITLS
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VITLS DeviceDevice
VITLS remote vital sign monitoring device will be applied to consented patients so data obtained by the device can be compared to data obtained by traditional inpatient hospital monitoring devices.
| Study group | Role | What they receive |
|---|---|---|
| VITLS Device | Experimental | The remote monitoring device (VITLS) will be placed onto the chest of consented patients in a manner that will not interfere with standard in-patient monitoring devices. Subjects will simultaneously be monitored with conventional inpatient methods per the unit routine. The providers caring for participating patients will be blinded to the data being collected by the remote monitoring system and no patient care decisions will be made based on the remote monitoring system. The remote monitoring device will automatically monitor and store the data for each subject by subject ID number. Once at least 6, but up to 72 hours of data have been recorded, the investigational device will be removed. Researchers will then retrospectively obtain the corresponding data from the current standard of care inpatient monitoring devices. Receives: Device: VITLS Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of pulse oximetry
Evaluate the VITLS device's ability to accurately measure pulse oximetry compared to conventional inpatient wall-connected methods in cardiac shunt-dependent children.
Measured: 6-72 hours
Secondary outcomes (2)
Evaluate the ability of VITLS to detect clinically significant SpO2 vital sign events compared to conventional inpatient methods.
Clinically significant SpO2 vital sign events are defined as SpO2 less than 75% or SpO2 greater than 90% sustained for 1 minute.
Measured: 6-72 hours
Evaluate the ability of VITLS to detect clinically significant Heart Rate vital sign events compared to conventional inpatient methods.
Clinically significant vital sign events are defined as heart rate less than 100 bpm or heart rate greater than 180 bpm sustained for 1 minute.
Measured: 6-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start26 Oct 2022
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest National Pediatric Device Innovation Consortium (SWPDC)
- Responsible party
- Principal investigator, Pamela Carol Petersen, Baylor College of Medicine
- Investigators
- Pamela C Petersen, MD, Principal investigator, Texas Children's Hospital/Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526768
- Sponsor's protocol ID
- H-46463
- Status last verified
- Jun 2024
- First submitted
- 30 Aug 2022
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Remote Vital Sign Monitor Compared to Traditional Inpatient Monitoring in Cardiac Shunt-Dependent Children
- ClinicalTrials.gov ID
- NCT05526768
- Acronym / sponsor ID
- H-46463
- Conditions
- Congenital Heart Disease, Desaturation of Blood
- Keywords
- remote monitoring, pulse oximeter, cardiac shunt dependent, Tego, VITLS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Southwest National Pediatric Device Innovation Consortium (SWPDC)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 2 Sep 2022 (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.
We are seeing how well a remote monitoring device that looks like a sticker placed on the chest, under the arm can monitor a child's vital signs including oxygen levels compared to the way that we usually get these measurements. The goal of this study is to see if the new sticker can be used for monitoring patients with cardiac shunt dependent heart conditions from home once they are discharged home. Participating children will be monitored for 6-72 hours with the new sticker in addition to his/her usual hospital monitors so the new sticker device can be compared to our hospital monitors.
Detailed description
Children with congenital heart disease who are cardiac shunt dependent are at increased risk for physiologic decompensation compared to non-shunt dependent children. This can lead to prolonged hospitalizations to facilitate careful vital sign monitoring to detect signs of deterioration early. While home monitoring programs have shown promise in this population, there is currently a shortage of pediatric specific remote monitoring devices that seamlessly provide vital sign results to caregivers and the healthcare team.
Over the past few years, home monitoring programs utilizing portable pulse oximetry to monitor oxygen saturation at home have reported improved survival in infants with single ventricle (cardiac shunt dependent) heart disease. Monitoring vital signs in cardiac shunt-dependent children presents challenges as most pulse oximeters are designed to monitor saturation levels greater than 85% SpO2 and shunt dependent children have baseline saturations closer to 75-85% SpO2. Additionally, traditional pulse oximetry probes are connected to a stationary monitor by leads of varying lengths. Children can easily remove these leads, thereby requiring frequent repositioning of the pulse oximeter. Additional limitations to current technology include inaccurate measurements due to motion artifact, need for frequent probe changes, parental requirement to log and interpret results, and the machines' lack of recording ability. An ideal monitor would be one that has continuous monitoring and recording features and provides feedback to the health care team in real time.
This study aims to evaluate a potential solution to some of the problems faced in home monitoring of cardiac shunt-dependent children. The proposed study device continuously measures pulse oximetry, heart rate, respiratory rate and temperature via a wireless probe that is placed on the child's chest. The device wirelessly transmits and stores the vital sign data continuously and can be accessed by authorized medical providers and the patient's caregivers at all times. The goal of this pilot study is to measure how the study device performs in comparison to standard-of-care hospital monitoring in the patients of interest.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VITLS Device | Experimental | Device: VITLS DeviceThe remote monitoring device (VITLS) will be placed onto the chest of consented patients in a manner that will not interfere with standard in-patient monitoring devices. Subjects will simultaneously be monitored with conventional inpatient methods per the unit routine. The providers caring for participating patients will be blinded to the data being collected by the remote monitoring system and no patient care decisions will be made based on the remote monitoring system. The remote monitoring device will automatically monitor and store the data for each subject by subject ID number. Once at least 6, but up to 72 hours of data have been recorded, the investigational device will be removed. Researchers will then retrospectively obtain the corresponding data from the current standard of care inpatient monitoring devices. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Cardiac shunt-dependent patients aged 0-1 year old located in the Texas Children's Hospital Cardiac Intensive Care Unit (CVICU)
Key exclusion criteria (7 listed)
- Presence of any implanted metal or electronic medical devices present in the chest (i.e. pace makers)
- Allergy to medical grade (latexfree) adhesive
- Any congenital or acquired desquamating skin condition (e.g., staphylococcal scalded skin syndrome, Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Any other medical condition which, in the opinion of the Investigator, could affect the participant's health during trial participation or could compromise his/her ability to participate in the trial.
- In the opinion of the investigator, the participant and his/her parent(s) or legal guardian(s) is not reliable for participation in the trial.
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 |
|---|---|---|
| VITLS DeviceVITLS remote vital sign monitoring device will be applied to consented patients so data obtained by the device can be compared to data obtained by traditional inpatient hospital monitoring devices. | Device | VITLS Device |
Primary outcome
Accuracy of pulse oximetry
Time frame: 6-72 hours
Evaluate the VITLS device's ability to accurately measure pulse oximetry compared to conventional inpatient wall-connected methods in cardiac shunt-dependent children.
2 secondary outcomes
Evaluate the ability of VITLS to detect clinically significant SpO2 vital sign events compared to conventional inpatient methods.
Time frame: 6-72 hours
Evaluate the ability of VITLS to detect clinically significant Heart Rate vital sign events compared to conventional inpatient methods.
Time frame: 6-72 hours
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 7 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Pamela C Petersen, MD principal investigator
Texas Children's Hospital/Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VITLS Device in people with Congenital Heart Disease and Desaturation of Blood, run by Baylor College of Medicine 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 7 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 7 Jun 2024. 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?
Accuracy of pulse oximetry (time frame: 6-72 hours). 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 7 Jun 2024.