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

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.

Study Overview

• Status: Completed
• Conditions: Technology
• Intervention / Treatment: Device: Novel smartphone application for blood pressure measurement

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients in the post-anesthesia care unit after their major surgery, equipped with an arterial line

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of blood pressure measurement done with the novel smartphone application versus the reference method	Comparison of values to invasive reference method (arterial line)	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of necessary measure to have a good relationship between both methods	Number of necessary measure to have a good relationship between both methods	Day of surgery
Usability assessment	Identification of possible use error in the manipulation of the device and in the performance of the measure	Day of surgery

Collaborators and Investigators

• Sponsor: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Actual): December 8, 2019
• Study Completion (Actual): December 8, 2019

Study Registration Dates

• First Submitted: October 5, 2019
• First Submitted That Met QC Criteria: October 5, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No