Blood Pressure, Heart Rate, Breathing Rate and Oxygen LevelMAC-VITALNCT04648111
Implementing Peri-operative Mobile Application for Contactless Vital Signs
An observational study of Blood Pressure, Heart Rate, Breathing Rate and Oxygen Level, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The huge impact of the COVID-19 pandemic on global healthcare systems has prompted search for novel tools to stem the tide. New digital health tools can provide possible health solutions in this time of unprecedented medical crisis to mitigate the impact of this pandemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure, Heart Rate, Breathing Rate and Oxygen Level
- What is being tested?
- Vital sign measurement
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jun 2021to 30 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia
Who may be able to join
- Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia
- 18 years or older
Who cannot join
- Refusal to consent for the study
- Non-English speaking.
Trial locations and contacts
1 site in 1 country.
Canada1 site
399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia
Toronto, Ontario, M5T2S8
About this study
Official title: Implementing Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial
The huge impact of the COVID-19 pandemic on global healthcare systems has prompted search for novel tools to stem the tide. New digital health tools can provide possible health solutions in this time of unprecedented medical crisis to mitigate the impact of this pandemic. This proof of concept study will determine the feasibility and effectiveness of implementing a mobile application for contactless measurement of vital signs (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR) and oxyhemoglobin saturation (SpO2) from surgical patients peri-operatively. Contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments. This study aims to determine whether a mobile app can effectively measure vital signs without any person to person contact and how this technology can be implemented in a peri-operative setting during COVID-19.
Read the detailed description
This study is a prospective proof of concept study to be conducted at Toronto Western Hospital,Toronto General Hospital, Hamilton General Hospital (Hamilton, Ontario), Juravinski Hospital (Hamilton, Ontario) and Trillium Health Partners, Mississauga, Ontario. This proof of concept study will determine the feasibility and effectiveness of implementing a contactless mobile application to obtain vital signs from patients in the peri-operative setting. Informed consent to participate in the study will be obtained.
Vital signs measurement will be obtained by the research staff using hospital standard medical devices and the Anura Research App will also be used to measure vital signs. Measurement will take place before surgery and post surgery (1 ±2hrs and 2 ±4hrs after surgery).
- Being tested
- Vital sign measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital sign measurementDiagnostic test
Vital signs measurement will be obtained by the research staff using hospital standard medical devices and the Anura Research App will also be used to measure vital signs. Measurement will take place before surgery and post surgery (1 ±2hrs and 2 ±4hrs after surgery).
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs measurement
Blood pressure will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measured: 24 hours
Vital signs measurement
Heart rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measured: 24 hours
Vital signs measurement
Breathing rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measured: 24 hours
Vital signs measurement
Heart rate variability will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measured: 24 hours
Vital signs measurement
Oxygen saturation will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start4 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure, Heart Rate, Breathing Rate and Oxygen LevelStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frances Chung, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648111
- Sponsor's protocol ID
- UHN CAPCR#20-5683
- Acronym
- MAC-VITAL
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial
- ClinicalTrials.gov ID
- NCT04648111
- Acronym / sponsor ID
- MAC-VITAL / UHN CAPCR#20-5683
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 1 Dec 2020 (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.
The huge impact of the COVID-19 pandemic on global healthcare systems has prompted search for novel tools to stem the tide. New digital health tools can provide possible health solutions in this time of unprecedented medical crisis to mitigate the impact of this pandemic. This proof of concept study will determine the feasibility and effectiveness of implementing a mobile application for contactless measurement of vital signs (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR) and oxyhemoglobin saturation (SpO2) from surgical patients peri-operatively. Contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments. This study aims to determine whether a mobile app can effectively measure vital signs without any person to person contact and how this technology can be implemented in a peri-operative setting during COVID-19.
Detailed description
This study is a prospective proof of concept study to be conducted at Toronto Western Hospital,Toronto General Hospital, Hamilton General Hospital (Hamilton, Ontario), Juravinski Hospital (Hamilton, Ontario) and Trillium Health Partners, Mississauga, Ontario. This proof of concept study will determine the feasibility and effectiveness of implementing a contactless mobile application to obtain vital signs from patients in the peri-operative setting. Informed consent to participate in the study will be obtained.
Vital signs measurement will be obtained by the research staff using hospital standard medical devices and the Anura Research App will also be used to measure vital signs. Measurement will take place before surgery and post surgery (1 ±2hrs and 2 ±4hrs after surgery).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia
Key inclusion criteria (2 listed)
- Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia
- 18 years or older
Key exclusion criteria (2 listed)
- Refusal to consent for the study
- Non-English speaking.
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 |
|---|---|---|
| Vital sign measurementVital signs measurement will be obtained by the research staff using hospital standard medical devices and the Anura Research App will also be used to measure vital signs. Measurement will take place before surgery and post surgery (1 ±2hrs and 2 ±4hrs after surgery). | Diagnostic test | – |
Primary outcome
Vital signs measurement
Time frame: 24 hours
Blood pressure will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Vital signs measurement
Time frame: 24 hours
Heart rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Vital signs measurement
Time frame: 24 hours
Breathing rate will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Vital signs measurement
Time frame: 24 hours
Heart rate variability will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Vital signs measurement
Time frame: 24 hours
Oxygen saturation will be measured by using both AnuraTM research app and standard medical grade Blood pressure machine pre-and post-operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Blood Pressure, Heart Rate, Breathing Rate and Oxygen Level, run by University Health Network, Toronto at 1 site in Canada.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 Nov 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital signs measurement (time frame: 24 hours). The study lists 5 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 2 Nov 2022.