- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04728477
Evaluation of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients
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
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1070
- Erasme
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All Intensive care unit patients with an arterial catheter for at least 48 hours
- Informed Consent as documented by signature
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
48 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability assessment
Time Frame: at 48 hour
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Identification of possible use error in the manipulation of the device and in the performance of the measure
|
at 48 hour
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2020/665
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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