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

Completed

• Conditions: Technology

• Registration Number: NCT04119193
• Lead Sponsor: Erasme University Hospital

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.

Study Timeline

• Study First Submitted: 2019-10-05
• Study First Submitted QC: 2019-10-05
• Study First Posted: 2019-10-08
• Study Start: 2019-11-12
• Status Verified: 2019-12
• Primary Completion: 2019-12-08
• Study Completion: 2019-12-08
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erasme; 🇧🇪 Brussels, Belgium