TechnologyNCT04121624
Evaluation of a Novel Mobile Phone Application ( OptiBP) for Blood Pressure Monitoring
An observational study of Technology, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Evaluation of a novel smartphone application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) and heart rate based on collected optical signals on patient's finger treated in the emergency department against the reference method (the oscillometric brachial cuff ) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Technology
- What is being tested?
- novel mobile phone application for blood pressure monitoring.
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Oct 2019to 8 Nov 2019
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Emergency department at Erasme hospital during one month (October 7 th until November 7 th 2019)
Who may be able to join
- Patients (Men or women) older than 18 years old admitted to the emergency department and in relatively good conditions to be able to participate in the study.
- Informed Consent as documented by signature
Who cannot join
- Minor patients
- Patients unable to participate due to the illness.
- Patients that cannot sign informed consent
- Patients extremely painful at the arrival (not possible for him to stay in a supine position).
- Blood pressure difference between the two arms >10mmHg
- Unstable patients requiring an urgent management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A New Mobile Phone Application for Blood Pressure Monitoring: A Comparison With the Oscillometric Brachial Cuff in Patients Treated in The Emergency Department
Evaluation of a novel smartphone application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) and heart rate based on collected optical signals on patient's finger treated in the emergency department against the reference method (the oscillometric brachial cuff )
Read the detailed description
The purpose of the study is to compare the blood pressure values measured by a novel smartphone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the oscillometric brachial cuff).
All patients admitted to the emergency department at Erasme Hospital Brussels, Belgium during 5 consecutive weeks will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry).
The OptiBP Application is a mobile application installed on a smartphone which is a non-invasive data-logger intended to acquire physiological data from patients. By applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure (+ heart rate), as well as patient's heart rate.
After having compared that the blood pressure in both arms are similar ( maximum of 10 mmHg of blood pressure difference between both arms), three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest (supine position).
The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (the oscillometric brachial cuff).
Then, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the novel mobile application.
The goal is therefore to compare blood pressure values as obtained by the analysis of the data recorded by the OptiBP Mobile Application, against simultaneous measurements provided by the oscillometric brachial cuff
- Conditions
- Technology
- Being tested
- novel mobile phone application for blood pressure monitoring.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
novel mobile phone application for blood pressure monitoring.Device
Comparative blood pressure measurement with the smartphone application and the non-invasive reference method (upper arm cuff).
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation of Blood pressure values measured simultanuously with the novel smartphone application
Comparision of values to non-invasive reference method (the oscillometric brachial cuff )
Measured: during a 6 minutes period of time in the emergency department.
Secondary outcomes (1)
Usability assessment
Identification of possible use error in the manipulation of the device and in the performance of the measure (finger position, contact pressure, etc).
Measured: during a 6 minutes period of time in the emergency department.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start7 Oct 2019
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TechnologyStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Joosten, MD PhD, Erasme University Hospital
- Investigators
- Alexandre J Joosten, MD PhD, Principal investigator, ERASME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121624
- Sponsor's protocol ID
- P2019/375
- Status last verified
- Nov 2019
- First submitted
- 3 Oct 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desebbe O, Tighenifi A, Jacobs A, Toubal L, Zekhini Y, Chirnoaga D, Collange V, Alexander B, Knebel JF, Schoettker P, Joosten A. Evaluation of a novel mobile phone application for blood pressure monitoring: a proof of concept study. J Clin Monit Comput. 2022 Aug;36(4):1147-1153. doi: 10.1007/s10877-021-00749-2. Epub 2021 Aug 18.
PubMed 34409513
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Mobile Phone Application for Blood Pressure Monitoring: A Comparison With the Oscillometric Brachial Cuff in Patients Treated in The Emergency Department
- ClinicalTrials.gov ID
- NCT04121624
- Acronym / sponsor ID
- P2019/375
- Conditions
- Technology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 10 Oct 2019 (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.
Evaluation of a novel smartphone application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) and heart rate based on collected optical signals on patient's finger treated in the emergency department against the reference method (the oscillometric brachial cuff )
Detailed description
The purpose of the study is to compare the blood pressure values measured by a novel smartphone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the oscillometric brachial cuff).
All patients admitted to the emergency department at Erasme Hospital Brussels, Belgium during 5 consecutive weeks will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry).
The OptiBP Application is a mobile application installed on a smartphone which is a non-invasive data-logger intended to acquire physiological data from patients. By applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure (+ heart rate), as well as patient's heart rate.
After having compared that the blood pressure in both arms are similar ( maximum of 10 mmHg of blood pressure difference between both arms), three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest (supine position).
The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (the oscillometric brachial cuff).
Then, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the novel mobile application.
The goal is therefore to compare blood pressure values as obtained by the analysis of the data recorded by the OptiBP Mobile Application, against simultaneous measurements provided by the oscillometric brachial cuff
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Emergency department at Erasme hospital during one month (October 7 th until November 7 th 2019)
Key inclusion criteria (2 listed)
- Patients (Men or women) older than 18 years old admitted to the emergency department and in relatively good conditions to be able to participate in the study.
- Informed Consent as documented by signature
Key exclusion criteria (6 listed)
- Minor patients
- Patients unable to participate due to the illness.
- Patients that cannot sign informed consent
- Patients extremely painful at the arrival (not possible for him to stay in a supine position).
- Blood pressure difference between the two arms >10mmHg
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 |
|---|---|---|
| novel mobile phone application for blood pressure monitoring.Comparative blood pressure measurement with the smartphone application and the non-invasive reference method (upper arm cuff). | Device | – |
Primary outcome
Confirmation of Blood pressure values measured simultanuously with the novel smartphone application
Time frame: during a 6 minutes period of time in the emergency department.
Comparision of values to non-invasive reference method (the oscillometric brachial cuff )
1 secondary outcome
Usability assessment
Time frame: during a 6 minutes period of time in the emergency department.
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 13 Nov 2019.
- Derived from this study: PubMed 34409513Desebbe O, Tighenifi A, Jacobs A, Toubal L, Zekhini Y, Chirnoaga D, Collange V, Alexander B, Knebel JF, Schoettker P, Joosten A. Evaluation of a novel mobile phone application for blood pressure monitoring: a proof of concept study. J Clin Monit Comput. 2022 Aug;36(4):1147-1153. doi: 10.1007/s10877-021-00749-2. Epub 2021 Aug 18.
- Individual participant dataSharing planned: No
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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.
Alexandre J Joosten, MD PhD principal investigator
ERASME
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 Technology, run by Erasme University Hospital at 1 site in Belgium.
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 6 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 13 Nov 2019. 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 Belgium. 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?
Confirmation of Blood pressure values measured simultanuously with the novel smartphone application (time frame: during a 6 minutes period of time in the emergency department.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121624, which also lists 1 linked publication.
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 13 Nov 2019.