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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).
'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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalised inpatients | Ten patients admitted into the Acute Care of the Elderly (ACE) ward will be approached for inclusion in the study. Patients will be given written information about the trial. Nursing staff looking after these patients will be asked to utilise the device after vital sign measurements obtained from standard hospital equipment when conducting routine vital sign measurements. Nurses will do this for the duration of the admission of 7days, thus generating 28 paired data points for comparison. |
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| Inpatients at home | Fifteen patients admitted into the home-based ward would be approached for inclusion in the study. Participants will undergo a 20 minute education session then be supplied with the device, companion app (user interface) on a mobile tablet, and written information about the trial. Participants will be asked to measure their vital signs four times a day, with one of those measurements occurring immediately after the clinical nurse' home review using standard hospital equipment for vital sign measurements (this matched pair of vital signs measurements will be taken as reference). Participants will do this for at least 7 days, thus generating 7 matched data points for comparison against reference, and 21 data points where participants independently conducted vital signs measurements with the Norbert sensor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device | Device | Validation of the combined device measurements compared with standard of care devices |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy validation - heart rate | Concordance 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. | 7 days |
| Accuracy validation - pulse oximetry for peripheral venous blood oxygen saturation | Concordance 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. | 7 days |
| Accuracy validation - temperature | Concordance 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. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Officer | Contact | 61393428530 | research@mh.org.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Melbourne Hospital | Recruiting | Melbourne | Victoria | Australia |
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| ID | Term |
|---|---|
| D013821 | Thermometers |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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