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Agreement and Precision of a Smartphone Application For Continuous Blood Pressure Monitoring

Agreement and Precision of a Novel Smartphone Application (OPTIBP) For Continuous Blood Pressure Monitoring: A Comparison With the Invasive Radial Arterial Catheter

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04119193
Enrollment
30
Registered
2019-10-08
Start date
2019-11-12
Completion date
2019-12-08
Last updated
2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Technology

Brief summary

Evaluation of an novel smartphone algorithm designed to estimate blood pressure based on collected optical signals on patients against the reference method, (radial arterial catheter) in patients admitted in the post anesthesia care unit after major surgeries.

Detailed description

The purpose of the study is to compare the blood pressure values measured by a mobile application used with a smartphone and the values measured by reference method, which is the radial arterial line 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.

Interventions

DEVICENovel 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.

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years

Inclusion criteria

* Adult patients in the post-anesthesia care unit after major surgery * equipped with an arterial catheters for perioperative management * Informed Consent as documented by signature * Good understanding of written and oral speaking

Exclusion criteria

* Patients that cannot sign informed consent * 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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of blood pressure measurement done with the novel smartphone application versus the reference methodDay of surgeryComparison of values to invasive reference method (arterial line)

Secondary

MeasureTime frameDescription
Number of necessary measure to have a good relationship between both methodsDay of surgeryNumber of necessary measure to have a good relationship between both methods
Usability assessmentDay of surgeryIdentification of possible use error in the manipulation of the device and in the performance of the measure

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026