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

F

Free University of Brussels (ULB)

Status

Completed

Conditions

Technology

Treatments

Device: Novel smartphone application for blood pressure measurement

Study type

Observational

Funder types

Other

Identifiers

NCT04119193
2019-375

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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