Contactless Vital Signs Measurement Study (CVMS)

NCT05886686 | Unknown

• 1 other identifier: RMH89542
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Vital Signs; Inpatients; Hospital-at-home

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Device: Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device

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.

Device: Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device

Interventions

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

Hospitalised inpatients; Inpatients at home

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Melbourne Health: lead

Study Sites (1)

Royal Melbourne Hospital

Melbourne, Victoria, Australia

RECRUITING

MeSH Terms

Interventions

Thermometers

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Central Study Contacts

Research Officer

CONTACT

61393428530; research@mh.org.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: June 2, 2023
• Study Start: April 5, 2023
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)