Agreement and Precision of a Smartphone Application For Continuous Blood Pressure Monitoring
NCT ID: NCT04119193
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
30 participants
OBSERVATIONAL
2019-11-12
2019-12-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients admitted to the post-anesthesia care unit after major surgeries (Erasme hospital)
Patient's arterial pressure will be measured with both measurement methods (novel smartphone application and the invasive arterial line).
The placement of an arterial line is standard of care in the investigators institution for patients scheduled for major surgeries. These patients spend 24 hours in the post-anesthesia care unit after their surgery for acute care management. Patient's blood pressure will be measured in parallel (same arm) with the mobile application and with the reference equipment (radial arterial line). Measures will be done during five times ( so five times one minute of recordings).
Blood pressure values obtained by the two methods will be compared to confirm the reliability of the data obtained with the mobile application.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Novel smartphone application for blood pressure measurement
Continuous blood pressure measurements will be compared between the new application and the reference method (invasive radial arterial line) during 5 minutes of recordings.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* equipped with an arterial catheters for perioperative management
* Informed Consent as documented by signature
* Good understanding of written and oral speaking
Exclusion Criteria
* Patients in emergency situation, are not legally competent, cannot understand the situation
* Known contact dermatitis to nickel/chromium
* Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation
* Lesion or deficiency on hand, preventing index obstruction of smartphone's camera
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Erasme University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alexandre Joosten, MD PhD
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexandre J Joosten, MD PhD
Role: PRINCIPAL_INVESTIGATOR
ERASME
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Erasme
Brussels, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-375
Identifier Type: -
Identifier Source: org_study_id