Vital SignsCVMSNCT05886686
Contactless Vital Signs Measurement Study (CVMS)
An observational study of Vital Signs and Inpatients, run by Melbourne Health at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Vital Signs, Inpatients, Hospital-at-home
- What is being tested?
- Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Apr 2023to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria
Research Officer, 61393428530
About this study
Official title: Validation of a Contactless Sensor for Measuring Vital Signs for Hospital Inpatients
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).
Read the 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
- Vital Signs, Inpatients, Hospital-at-home
- Being tested
- Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement deviceDevice
Validation of the combined device measurements compared with standard of care devices
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start5 Apr 2023
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886686
- Sponsor's protocol ID
- RMH89542
- Acronym
- CVMS
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Contactless Sensor for Measuring Vital Signs for Hospital Inpatients
- ClinicalTrials.gov ID
- NCT05886686
- Acronym / sponsor ID
- CVMS / RMH89542
- Conditions
- Vital Signs, Inpatients, Hospital-at-home
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalised inpatients | – | Device: Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement deviceTen 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 | – | Device: Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement deviceFifteen 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of the accuracy of a combined oximeter, thermometer and heart rate measurement deviceValidation of the combined device measurements compared with standard of care devices | Device | Hospitalised inpatients, Inpatients at home |
Primary outcome
Accuracy validation - heart rate
Time frame: 7 days
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.
Accuracy validation - pulse oximetry for peripheral venous blood oxygen saturation
Time frame: 7 days
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.
Accuracy validation - temperature
Time frame: 7 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Vital Signs
Enrolling by invitationObservational study
Knowledge of Vital Pulp Therapy in Permanent Teeth After Educational Programme: A Before and After Study
Pulp Disease, Dental, Knowledge
Not yet recruiting
Therapeutic Holding Versus Traditional Restraint During Pediatric Venipuncture
Pediatric Venipuncture
Recruiting
VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
Anxiety
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Recruiting
Hospital Based Continuous Patient Monitoring System
Trauma, Appendectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs and Inpatients, run by Melbourne Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Research Officer (61393428530, research@mh.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy validation - heart rate (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.