Clinical trial NCT05886686: Contactless Vital Signs Measurement Study (CVMS)
Official title: Validation of a Contactless Sensor for Measuring Vital Signs for Hospital Inpatients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vital Signs
Inpatients
Hospital-at-home
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted patients that will require routine vital signs measurements with routine hospital equipment as part of standard of care; who will also be able to utilise a contactless vital sign measurement device at a matched timeframe to their routine vital signs measurements.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy validation - heart rate
timeFrame: 7 days
measure: Accuracy validation - pulse oximetry for peripheral venous blood oxygen saturation
timeFrame: 7 days
measure: Accuracy validation - temperature
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
Study officials:
References: