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

Trial Summary

What is the purpose of this trial?

Small connected devices monitoring vital signs do not exist in children although they could be very useful to monitor patients once they have left the pediatric intensive care unit (PICU) in order to early identify patients at risk of PICU readmission. 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 patients. 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 Philips monitoring system. The investigators will assess the device's accuracy for the monitoring of 4 vital signs (SpO2, heart rate, respiratory rate and temperature) and perform exploratory assessment of three additional parameters (EKG, blood pressure and movement capture). The skin colour of each participant will be categorized based on Fitzpatrick scale and non-invasive spectroscopic method.

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 data supports the effectiveness of the treatment VTPatch for monitoring vital signs?

The research on similar devices like VitalPatch and Vitalstream shows that continuous, wireless monitoring of vital signs can improve patient care by detecting issues early. These devices have been validated for accuracy in measuring heart rate, breathing rate, and other vital signs, suggesting that VTPatch could be effective for similar purposes. ^{1 2 3 4 5}

Is the VT-Patch generally safe for human use?

There is no specific safety data available for the VT-Patch or VTPatch in the provided research articles. ^{6 7 8 9 10}

How is the VT-Patch treatment different from other treatments for monitoring vital signs?

The VT-Patch is unique because it is a fully disposable wireless biosensor that allows for continuous remote monitoring of vital signs, unlike traditional methods that often involve cumbersome equipment and frequent interruptions. This patch-based system can detect clinically meaningful events that might be missed by conventional monitoring, making it a novel approach for patient care. ^{1 3 4 5 11}

Research Team

Philippe Jouvet, MD, PhD

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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 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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A new continuous noninvasive finger cuff device (Vitalstream) for cardiac output that communicates wirelessly via bluetooth or Wi-Fi. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

The Use of Head-Worn Displays for Vital Sign Monitoring in Critical and Acute Care: Systematic Review. [2021]

3. England 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. [2021]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Fully Disposable Wireless Patch Sensor for Continuous Remote Patient Monitoring. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms. [2020]

7. United States 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. New Zealand 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. [2018]

10. England pubmed.ncbi.nlm.nih.gov

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

11. United States 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. [2020]