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Contactless Vital Signs Measurement Study (CVMS)

Validation of a Contactless Sensor for Measuring Vital Signs for Hospital Inpatients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05886686
Acronym
CVMS
Enrollment
30
Registered
2023-06-02
Start date
2023-04-05
Completion date
2023-09-30
Last updated
2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital-at-home, Inpatients, Vital Signs

Brief summary

This study asks the question - Can vital signs be accurately measured via a contactless device and can this be independently done by inpatients in their homes? Primary objectives are to validate the accuracy of contactless vital sign measurements in comparison with vital signs measurements of heart rate, oxygen saturation, temperature using standard ward equipment (the reference standard).

Detailed description

'Vital signs' such as heart rate (HR), temperature and peripheral blood oxygen saturation (SpO2) are routinely measured four times a day amongst hospitalised patients. However, this frequency of monitoring is unable to be replicated amongst patients in the RMH@Home Acute program. Also known as Hospital In The Home (HITH), RMH@Home Acute nurses and doctors deliver treatments to patients at home in substitution for a hospital admission. Home-based reviews are conducted one to two times daily, with more frequent reviews limited by travelling times and geographical constraints. Accordingly, this study aims to investigate the accuracy and user-friendliness of new contactless technology to measure patients 'vital signs', paving the way towards enabling home-based patients to independently measure their vital signs during their admission. Besides enabling increased frequency of routine monitoring, this technology can also be applied to improve ad hoc assessments when patients report clinical concerns by enabling vital signs to be remotely measured by patients and/or their carers whilst clinicians travel to their homes to deliver treatment. Results from publication of this study will add to lexicon of knowledge regarding the utility of remote monitoring devices in monitoring and detecting clinical deterioration amongst hospitalized patients at home. In this two-stage study, participants' vital signs obtained by the new contactless sensor are first compared with standard vital sign measurements obtained by nursing staff on the hospital ward. Should the sensor be found to obtain similar measurements thus indicating accuracy and feasibility of use amongst hospital patients, the second stage of this study involves investigating the feasibility of participants utilising these devices to measure their vital signs in the home-setting.

Interventions

DEVICEValidation of the accuracy of a combined oximeter, thermometer and heart rate measurement device

Validation of the combined device measurements compared with standard of care devices

Sponsors

Melbourne Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

Inclusion criteria

* Admitted inpatients within two hospital wards * Patients expected to remain admitted within the two wards over 7 days of the study for availability of their vital sign measurements * technological capability to utilise the device's companion app, as evidenced by ownership and utilisation of a 'smart' device (eg smartphone)

Exclusion criteria

* Cognitive disability impeding participants' ability to independently conduct vital sign measurements * Clinical instability impeding participants' ability to independently conduct vital sign measurements * Physical concerns (e.g. manual dexterity) impeding participants' ability to independently conduct vital sign measurements * Environmental and technical issues such as lack of home Wi-Fi system, location of home in a 'Wi-Fi black spot', or unsafe home environments, that impede participants' ability to independently conduct vital sign measurements

Design outcomes

Primary

MeasureTime frameDescription
Accuracy validation - heart rate7 daysConcordance of heart rate (beats per minute) measurements via the test device in comparison with nurse-conducted measurements of heart rate using standard ward equipment (reference standard). These measurements are deemed to be similar and acceptable for clinical purposes if within +/- 10% of the reference standard.
Accuracy validation - pulse oximetry for peripheral venous blood oxygen saturation7 daysConcordance of pulse oximetry (percentage saturation) measurements via the test device in comparison with nurse-conducted pulse oximetry measurements of peripheral blood oxygen saturation using standard ward equipment (reference standard). These measurements are deemed to be similar and acceptable for clinical purposes if within +/- 10% of the reference standard.
Accuracy validation - temperature7 daysConcordance of peripheral temperature (degree celsius) measurements via the test device in comparison with nurse-conducted temperature measurements using standard ward equipment (reference standard). These measurements are deemed to be similar and acceptable for clinical purposes if within +/- 10% of the reference standard.

Countries

Australia

Contacts

Primary ContactResearch Officer
research@mh.org.au61393428530

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026