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UnknownNCT05886686

Contactless Vital Signs Measurement Study (CVMS)

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

Status
Unknown
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Melbourne Health · Academic / Other
Sex
All
Age
18 Years – 110 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEValidation of the accuracy of a combined oximeter, thermometer and heart rate measurement deviceValidation of the combined device measurements compared with standard of care devices

Timeline

Start date
2023-04-05
Primary completion
2023-07-01
Completion
2023-09-01
First posted
2023-06-02
Last updated
2023-06-06

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT05886686. Inclusion in this directory is not an endorsement.