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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05886686




Registration number
NCT05886686
Ethics application status
Date submitted
21/03/2023
Date registered
2/06/2023
Date last updated
6/06/2023

Titles & IDs
Public title
Contactless Vital Signs Measurement Study (CVMS)
Scientific title
Validation of a Contactless Sensor for Measuring Vital Signs for Hospital Inpatients
Secondary ID [1] 0 0
RMH89542
Universal Trial Number (UTN)
Trial acronym
CVMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vital Signs 0 0
Inpatients 0 0
Hospital-at-home 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device

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.

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.


Treatment: Devices: Validation 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Accuracy validation - heart rate
Timepoint [1] 0 0
7 days
Primary outcome [2] 0 0
Accuracy validation - pulse oximetry for peripheral venous blood oxygen saturation
Timepoint [2] 0 0
7 days
Primary outcome [3] 0 0
Accuracy validation - temperature
Timepoint [3] 0 0
7 days

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT05886686
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Research Officer
Address 0 0
Country 0 0
Phone 0 0
61393428530
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05886686