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

NCT04119193 | Completed

• 1 other identifier: 2019-375
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of necessary measure to have a good relationship between both methods

  Day of surgery

• Usability assessment

  Day of surgery

Interventions

Novel smartphone application for blood pressure measurement DEVICE

Continuous blood pressure measurements will be compared between the new application and the reference method (invasive radial arterial line) during 5 minutes of recordings.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme

Brussels, 1070, Belgium

Location

MeSH Terms

Interventions

Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Officials

• Alexandre J Joosten, MD PhD

  ERASME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2019
• First Posted: October 8, 2019
• Study Start: November 12, 2019
• Primary Completion: December 8, 2019
• Study Completion: December 8, 2019
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)