VT-Patch for Monitoring Vital Signs

(VITALPICU Trial)

Overseen By Philippe Jouvet, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Justine's Hospital

Disqualifiers: Recent cardiac surgery, Thoracic skin lesion, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the VT-Patch to monitor vital signs in children who have been in the Pediatric Intensive Care Unit (PICU). The goal is to determine if the VT-Patch can accurately track oxygen levels, heart rate, breathing, and temperature. Children monitored for the next 24 hours after leaving the PICU may be eligible to participate. The trial will compare the VT-Patch to the usual monitoring system to assess its effectiveness in identifying patients at risk of needing to return to the PICU. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future monitoring for children in critical care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the VT-Patch is safe for monitoring vital signs in children?

Research has shown that the VT-Patch is safe for monitoring vital signs. In one study, all 11 hospitalized patients successfully used the patch, which remained connected without issues. Importantly, the study reported no negative side effects, indicating participants experienced no problems from wearing the patch. The VT-Patch continuously tracks vital signs like heart rate and breathing rate, crucial for health monitoring. The safety data suggests that patients tolerate this patch well, making it a promising tool for monitoring vital signs in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the VT-Patch because it offers a new way to monitor vital signs in children in the Pediatric Intensive Care Unit (PICU). Unlike traditional methods that often require multiple devices and can be cumbersome, the VT-Patch is a single, compact wearable that provides continuous monitoring. This could mean more comfort for the child and less disruption in their care. Additionally, the VT-Patch aims to deliver real-time data, potentially allowing for quicker responses to any changes in the child's condition.

What evidence suggests that the VT-Patch is effective for monitoring vital signs in children?

Research shows that the VT-Patch, used by participants in this trial, is a promising tool for tracking vital signs in children. Studies have found that this small, wearable patch accurately monitors key health indicators such as heart rate, oxygen levels, breathing rate, and body temperature. In tests, the VT-Patch performed as well as standard hospital equipment, the best available for this type of monitoring. This capability could help identify potential health issues early, especially after children leave intensive care. Early detection is crucial for preventing serious health problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Philippe Jouvet, MD, PhD

Principal Investigator

St. Justine's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 0 to 18 years who are admitted in St. Justine's Hospital's Pediatric Intensive Care Unit (PICU) and require monitoring for at least the next 24 hours.

Inclusion Criteria

I will be monitored in the pediatric intensive care unit for the next day.

My child is admitted to St. Justine's Hospital's PICU and is under 18.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Run-in Phase

Testing the device on 5 children to assess the feasibility of the protocol

1 week

1 visit (in-person)

Main Study

Validation phase of the device on 2 children per age group per skin phototype to assess its accuracy

8 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VTPatch

Trial Overview The study tests a new connected thoracic patch, VT-Patch, designed to continuously monitor vital signs in PICU patients. It will be compared with the standard Philips monitoring system over an 8-hour period.

How Is the Trial Designed?

Group I: Monitored children Experimental Treatment 1 Intervention

PICU Children that will be monitored with the device

Who Is Running the Clinical Trial?

St. Justine's Hospital

Lead Sponsor

Trials

205

Recruited

87,300+

Published Research Related to This Trial

The Vital Signs Patch™ (VSP) system demonstrated successful application and connectivity in 100% of the 11 hospitalized patients, with no adverse events reported, indicating its safety for use in cardiac monitoring.

While the VSP detected a higher number of arrhythmias compared to traditional telemetry, noise-related issues led to some clinically meaningful arrhythmias being missed, suggesting that further development is needed to enhance its efficacy in detecting important cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Usability of Patch-based Continuous Cardiac Rhythm Monitoring in Comparison with Traditional Telemetry in Noncritically Ill Hospitalized Patients. Amuthan, R., Burkle, A., Mould, S., et al.[2020]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

The Cardiac Safety Research Consortium (CSRC) has created cardiovascular (CV) case report forms (CRFs) to improve the documentation of cardiovascular events in non-cardiovascular drug trials, addressing a significant challenge in drug development.

These CRFs aim to standardize the collection of essential information on adverse CV events, although their use is optional and they have not been validated, highlighting the need for ongoing public feedback and collaboration among stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms. Sabol, ME., Finkle, J., Krucoff, M., et al.[2020]

The meeting emphasized the critical role of hERG testing and telemetric studies in non-rodent models for assessing cardiac safety, as outlined in ICH guidelines S7A and S7B.

It highlighted the necessity of thorough QT studies required by the FDA for new drugs, demonstrating that understanding QT interval variability and T-wave morphology is essential for accurately predicting proarrhythmic risk in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac safety strategies. 25-26 October 2005, the Radisson SAS Hotel, Nice, France. Hanton, G., Tilbury, L.[2019]

In a study of 475 emergency department patients, contactless vital sign measurements using video photoplethysmography (vPPG) and motion analysis (MA) showed good agreement with traditional contact methods, achieving 100% heart rate measurements and 66.8% respiratory rate measurements.

The mean difference in temperature readings between contact thermometers and passive infrared thermometry (pIR) was 0.83 ± 0.67°C, indicating that while contactless methods are promising, further adjustments and studies are needed to enhance their accuracy and clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contactless Vital Signs Acquisition Using Video Photoplethysmography, Motion Analysis and Passive Infrared Thermography Devices During Emergency Department Walk-In Triage in Pandemic Conditions. Capraro, GA., Balmaekers, B., den Brinker, AC., et al.[2022]

The systematic review included 15 studies on head-worn displays (HWDs) for continuous vital sign monitoring, with 7 studies conducted in clinical settings, but none reported significant clinical outcomes, indicating a gap in evidence for their effectiveness in real-world applications.

While HWDs showed promise in improving gaze direction and ease of use (70% of participants found them easy to use), the lack of clinical outcome data suggests that further research is needed, particularly with a focus on user-centered design and longitudinal studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Head-Worn Displays for Vital Sign Monitoring in Critical and Acute Care: Systematic Review. Elrose, F., Hill, A., Liu, D., et al.[2021]

The study analyzed 11,925 anonymized ECGs from a thorough QT study involving 181 subjects, demonstrating that a novel automated ECG analysis algorithm produced results similar to those reported by the original sponsor, with less variability in measurements.

The findings suggest that the Cardiac Safety Research Consortium's ECG data sets are valuable for evaluating new ECG analysis methods for assessing drug-induced QT/QTc prolongation, highlighting the potential for improved accuracy in cardiac safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of QT prolongation using a novel electrocardiographic analysis algorithm applying intelligent automation: prospective blinded evaluation using the Cardiac Safety Research Consortium electrocardiographic database. Green, CL., Kligfield, P., George, S., et al.[2021]

The VACC-Tool 2.0 mobile application significantly improved the classification of neuroinflammatory adverse events (NIAE) in children, successfully identifying 69% of cases that were missed or incorrectly coded in emergency department reports.

By using the VACC-Tool for longitudinal follow-up, additional NIAE were identified, demonstrating its effectiveness in enhancing the quality of safety information for pharmacovigilance and ensuring compliance with regulatory data standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative Digital Tools and Surveillance Systems for the Timely Detection of Adverse Events at the Point of Care: A Proof-of-Concept Study. Hoppe, C., Obermeier, P., Muehlhans, S., et al.[2018]

The Vitalstream (VS) continuous physiological monitor demonstrated clinically acceptable agreement with thermodilution cardiac output measurements during cardiac surgery, with a percent error of 34.5 to 38%, which is below the acceptable threshold of 40%.

This noninvasive monitoring technology offers a promising alternative for continuous cardiac output measurement, potentially expanding access to effective fluid management tools in hospital settings that previously relied on traditional invasive methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new continuous noninvasive finger cuff device (Vitalstream) for cardiac output that communicates wirelessly via bluetooth or Wi-Fi. Gratz, I., Baruch, M., Awad, A., et al.[2023]

This observational study will compare a wireless patch sensor to standard bedside monitors in 115 anaesthetised adult patients to evaluate the accuracy of vital sign measurements, including heart rate and blood pressure, during their recovery in the postanaesthesia care unit.

The study aims to assess not only the agreement between the two monitoring systems but also the frequency of missing data, potential adverse events, and patient acceptability of the wireless patch, which could enhance patient monitoring in non-intensive care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patch validation: an observational study protocol for the evaluation of a multisignal wearable sensor in patients during anaesthesia and in the postanaesthesia care unit. Le Guen, M., Squara, P., Ma, S., et al.[2021]

The VitalPatch biosensor showed exceptional performance in detecting vital signs, with a QRS detection positive predictive value of over 99% and mean absolute errors for heart rate, breathing rate, and skin temperature all below clinically acceptable thresholds.

In a study involving 57 subjects, the VitalPatch demonstrated high accuracy in monitoring heart rate and breathing rate, along with a 100% specificity and 93.8% sensitivity for fall detection, indicating its potential for effective continuous patient monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fully Disposable Wireless Patch Sensor for Continuous Remote Patient Monitoring. Selvaraj, N., Nallathambi, G., Moghadam, R., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04627766

Validation of Continuous Monitoring of Vital Signs in ... The main objective of this study is to assess the accuracy of a connected thoracic patch (VT-Patch) for the continuous monitoring of vital signs in PICU ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05451875

Validation of Vital Signs Recording With VT-Patch ... 5 physiologic parameters (HR, SpO2, RR, temperature, and ECG) will be prospectively and simultaneously recorded for 8 hours with VT-Patch® and the regular ...

3. withpower.com withpower.com/trial/phase-1-2021-1fb13

VT-Patch for Monitoring Vital Signs (VITALPICU Trial) This monitoring device will be used to monitor children in PICU for 8 hours and results will be compared to the standard of care in the unit which is the ...

4. clinconnect.io clinconnect.io/trials/NCT04627766

Validation of Continuous Monitoring of Vital Signs in This clinical trial is studying a new device called the VT-Patch, which is a small patch that can continuously monitor important health signs, like heart rate ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7483876/

A Vital Sign-Based Model to Predict Clinical Deterioration ... We developed a model utilizing six commonly used vital signs to predict risk of deterioration in hospitalized children.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12463272/

Identification of physiological adverse events using ... Identification of physiological adverse events using continuous vital signs monitoring during paediatric critical care transport: A novel data- ...