HypotensionNCT04728477
Evaluation of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients
An observational study of Hypotension, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in intensive care unit patients Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hypotension
- What is being tested?
- OPti BP measurements
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Feb 2021to 1 Apr 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All intensive care unit patients with an arterial catheter for at least 48 hours
Who may be able to join
- All Intensive care unit patients with an arterial catheter for at least 48 hours
- Informed Consent as documented by signature
Who cannot join
- Patients or families that cannot sign informed consent
- Patients in emergency situation, and unstable
- Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
- Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
- Known contact dermatitis to nickel/chromium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy, Precision and Trending Abilities of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients: A Method Comparison Study Against the Arterial Line as the Reference Method
Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in intensive care unit patients
Read the detailed description
The purpose of the study is to compare the blood pressure values measured by a novel mobile phone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the radial arterial line)
All patients admitted in the intensive care unit at Erasme Hospital Brussels, Belgium will be recruited and if they have an arterial line for at least two days
The OptiBP Application is a mobile application installed on a mobile phone 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.
Three measures will be taken (spaced by one minute) with both methods each hour for 5 hours and this will be done for 2 days.
The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (arterial line).
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 arterial line (gold standard)
- Conditions
- Hypotension
- Being tested
- OPti BP measurements
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPti BP measurementsDevice
measurement of blood pressure with the new smartphone App ( OPTIBP)
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of blood pressure between the new smartphone App and the radial arterial line
Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).
Measured: 48 hours
Secondary outcomes (1)
Usability assessment
Identification of possible use error in the manipulation of the device and in the performance of the measure
Measured: at 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start3 Feb 2021
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
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 HypotensionStudies 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 (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 JOOSTEN, MD PhD, Principal investigator, ERASME
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728477
- Sponsor's protocol ID
- P2020/665
- Status last verified
- Nov 2021
- First submitted
- 24 Jan 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desebbe O, Anas C, Alexander B, Kouz K, Knebel JF, Schoettker P, Creteur J, Vincent JL, Joosten A. Evaluation of a novel optical smartphone blood pressure application: a method comparison study against invasive arterial blood pressure monitoring in intensive care unit patients. BMC Anesthesiol. 2022 Aug 15;22(1):259. doi: 10.1186/s12871-022-01797-0.
PubMed 35971072
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy, Precision and Trending Abilities of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients: A Method Comparison Study Against the Arterial Line as the Reference Method
- ClinicalTrials.gov ID
- NCT04728477
- Acronym / sponsor ID
- P2020/665
- Conditions
- Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 28 Jan 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.
Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in intensive care unit patients
Detailed description
The purpose of the study is to compare the blood pressure values measured by a novel mobile phone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the radial arterial line)
All patients admitted in the intensive care unit at Erasme Hospital Brussels, Belgium will be recruited and if they have an arterial line for at least two days
The OptiBP Application is a mobile application installed on a mobile phone 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.
Three measures will be taken (spaced by one minute) with both methods each hour for 5 hours and this will be done for 2 days.
The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (arterial line).
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 arterial line (gold standard)
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
- All intensive care unit patients with an arterial catheter for at least 48 hours
Key inclusion criteria (2 listed)
- All Intensive care unit patients with an arterial catheter for at least 48 hours
- Informed Consent as documented by signature
Key exclusion criteria (5 listed)
- Patients or families that cannot sign informed consent
- Patients in emergency situation, and unstable
- Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
- Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
- Known contact dermatitis to nickel/chromium
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 |
|---|---|---|
| OPti BP measurementsmeasurement of blood pressure with the new smartphone App ( OPTIBP) | Device | – |
Primary outcome
Comparison of blood pressure between the new smartphone App and the radial arterial line
Time frame: 48 hours
Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).
1 secondary outcome
Usability assessment
Time frame: at 48 hour
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 19 Nov 2021.
- Derived from this study: PubMed 35971072Desebbe O, Anas C, Alexander B, Kouz K, Knebel JF, Schoettker P, Creteur J, Vincent JL, Joosten A. Evaluation of a novel optical smartphone blood pressure application: a method comparison study against invasive arterial blood pressure monitoring in intensive care unit patients. BMC Anesthesiol. 2022 Aug 15;22(1):259. doi: 10.1186/s12871-022-01797-0.
- 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 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 Hypotension, 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 5 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 19 Nov 2021. 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?
Comparison of blood pressure between the new smartphone App and the radial arterial line (time frame: 48 hours). 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 NCT04728477, 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 19 Nov 2021.