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

Technology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119193
• Other study ID #: 2019-375
• Status: Completed
• Start date: November 12, 2019
• Est. completion date: December 8, 2019

Study information

• Verified date: December 2019
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 8, 2019
• Est. primary completion date: December 8, 2019
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Technology

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Belgium	Erasme	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Usability assessment	Identification of possible use error in the manipulation of the device and in the performance of the measure	Day of surgery