Clinical trial NCT04119193: Agreement and Precision of a Smartphone Application For Continuous Blood Pressure Monitoring
Official title: Agreement and Precision of a Novel Smartphone Application (OPTIBP) For Continuous Blood Pressure Monitoring: A Comparison With the Invasive Radial Arterial Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Technology
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients in the post-anesthesia care unit after their major surgery, equipped with an arterial line

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of blood pressure measurement done with the novel smartphone application versus the reference method
timeFrame: Day of surgery
Secondary outcomes:
measure: Number of necessary measure to have a good relationship between both methods
timeFrame: Day of surgery
measure: Usability assessment
timeFrame: Day of surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme
Study officials:
affiliation: ERASME
name: Alexandre J Joosten, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: