Vital SignsMAC-VITALNCT04976907
Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement
An observational study of Vital Signs, run by Nuralogix Corporation at 4 sites in Canada.
Trial summary
The impact of the coronavirus disease (COVID)-19 pandemic on global healthcare systems has prompted a 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
- Vital Signs
- What is being tested?
- Contactless vital sign information collection
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Oct 2021to 1 Oct 2022
- 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
- Adult, Older adult
Study population: Patients scheduled to undergo elective surgery under general and/or regional anesthesia.
Who may be able to join
- Patients scheduled to undergo elective surgery under general and/or regional anesthesia
- 18+ years of age
Who cannot join
- Refusal to consent for the study
- Non-English speaking
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Hamilton General Hospital (Hamilton Health Sciences)
Hamilton, Ontario, L8L 2X2
Russel Brown, MD, 905-521-2100 ext. 44890, russell.brown@medportal.ca
Juravinski Hospital (Hamilton Health Sciences)
Hamilton, Ontario, L8V 1C3
Russel Brown, MD, 905-521-2100 ext. 44890, russell.brown@medportal.ca
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Matteo Parotto, MD PhD, (416) 340-3567, Matteo.Parotto@uhn.ca
Toronto Western Hospital, University Health Network
Toronto, Ontario, M5T 2S8
Frances Chung, MBBS, FRCPC, (416) 670-4253, Frances.Chung@uhn.ca
About this study
Official title: Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial
The impact of the coronavirus disease (COVID)-19 pandemic on global healthcare systems has prompted a 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 screening and vital signs measurement (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR), oxyhemoglobin saturation (SpO2), temperature from surgical patients peri-operatively. Contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments.
Read the detailed description
This study aims to determine whether a mobile app can accurately and reliably measure vital signs without any person to person contact, and the feasibility of implementing it in a peri-operative setting (e.g., during COVID-19). The validity and feasibility of the Anura™ Research app will be assessed during inpatient visits in preparation for and after surgery, and it will be compared with standard medical monitors.
- Conditions
- Vital Signs
- Being tested
- Contactless vital sign information collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contactless vital sign information collectionDevice
Collection of facial blood flow and temperature information via conventional and infrared/thermal video of the face for the purpose of estimating vital signs using machine learning-based computational models.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative patients | Patients undergoing perioperative assessment of vital signs. Receives: Device: Contactless vital sign information collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Measured: Perioperative
Diastolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Measured: Perioperative
Blood oxygenation (SpO2) difference from reference measurement (% oxyhemoglobin saturation)
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (% oxyhemoglobin saturation)
Measured: Perioperative
Pulse rate difference from reference measurement (beats per minute)
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute)
Measured: Perioperative
Teperature difference from reference measurement (degrees Celsius)
Assessed against standard clinical grade instrument: Forehead digital thermometer (degrees Celsius)
Measured: Perioperative
Respiratory rate difference from reference measurement (breaths per minute)
Assessed against standard clinical grade instrument: Visual count of chest rise and fall (breaths per minute)
Measured: Perioperative
Obstacles to using the mobile application
Characterization of obstacles to the implementation of the mobile app for perioperative vital sign measurements.
Measured: Perioperative
Secondary outcomes (5)
Detection rate of clinically meaningful changes of vital signs
Proportion of clinically meaningful vital sign changes detected postoperatively by the mobile application (relative to vital sign changes detected by standard clinical grade instruments).
Measured: Perioperative
Ease of use survey
Visual analog scale for ease of use.
Measured: Perioperative
Satisfaction survey
Visual analog scale for satisfaction.
Measured: Perioperative
Study participation
Includes: Proportion of patients approached who join the study, proportion of patients who own a mobile phone
Measured: Perioperative
Compliance with measurement protocol
Includes: Proportion of patients who comply with the measurement protocol
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuralogix Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Frances Chung, MBBS, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976907
- Sponsor's protocol ID
- 1
- Acronym
- MAC-VITAL
- Status last verified
- Sep 2021
- First submitted
- 15 Jul 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Mobile Application for Contactless Screening and Vital Signs Measurement (MAC-VITAL): A Proof of Concept Trial
- ClinicalTrials.gov ID
- NCT04976907
- Acronym / sponsor ID
- MAC-VITAL / 1
- Conditions
- Vital Signs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nuralogix CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto, Hamilton Health Sciences Corporation
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 26 Jul 2021 (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 impact of the coronavirus disease (COVID)-19 pandemic on global healthcare systems has prompted a 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 screening and vital signs measurement (MAC-VITAL) such as blood pressure (BP), heart rate (HR), respiratory rate (RR), oxyhemoglobin saturation (SpO2), temperature from surgical patients peri-operatively. Contactless measurement of vital signs will bridge the current gap between virtual care and in-person medical assessments.
Detailed description
This study aims to determine whether a mobile app can accurately and reliably measure vital signs without any person to person contact, and the feasibility of implementing it in a peri-operative setting (e.g., during COVID-19). The validity and feasibility of the Anura™ Research app will be assessed during inpatient visits in preparation for and after surgery, and it will be compared with standard medical monitors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perioperative patients | – | Device: Contactless vital sign information collectionPatients undergoing perioperative assessment of vital signs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo elective surgery under general and/or regional anesthesia.
Key inclusion criteria (2 listed)
- Patients scheduled to undergo elective surgery under general and/or regional anesthesia
- 18+ years of age
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 |
|---|---|---|
| Contactless vital sign information collectionCollection of facial blood flow and temperature information via conventional and infrared/thermal video of the face for the purpose of estimating vital signs using machine learning-based computational models. | Device | Perioperative patients |
Primary outcome
Systolic blood pressure difference from reference measurement (mmHg)
Time frame: Perioperative
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Diastolic blood pressure difference from reference measurement (mmHg)
Time frame: Perioperative
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Blood oxygenation (SpO2) difference from reference measurement (% oxyhemoglobin saturation)
Time frame: Perioperative
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (% oxyhemoglobin saturation)
Pulse rate difference from reference measurement (beats per minute)
Time frame: Perioperative
Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute)
Teperature difference from reference measurement (degrees Celsius)
Time frame: Perioperative
Assessed against standard clinical grade instrument: Forehead digital thermometer (degrees Celsius)
Respiratory rate difference from reference measurement (breaths per minute)
Time frame: Perioperative
Assessed against standard clinical grade instrument: Visual count of chest rise and fall (breaths per minute)
Obstacles to using the mobile application
Time frame: Perioperative
Characterization of obstacles to the implementation of the mobile app for perioperative vital sign measurements.
5 secondary outcomes
Detection rate of clinically meaningful changes of vital signs
Time frame: Perioperative
Ease of use survey
Time frame: Perioperative
Satisfaction survey
Time frame: Perioperative
Study participation
Time frame: Perioperative
Compliance with measurement protocol
Time frame: Perioperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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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.
Frances Chung, MBBS, FRCPC principal investigator
University Health Network, Toronto
4 sites 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, run by Nuralogix Corporation at 4 sites 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: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frances Chung, MBBS, FRCPC ((416) 670-4253, Frances.Chung@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure difference from reference measurement (mmHg) (time frame: Perioperative). The study lists 7 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 14 Sep 2021.