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OpenTrials
Completed

NCT Number: NCT04119193

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

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.

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme

Brussels, 1070, Belgium

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Comparison of blood pressure measurement done with the novel smartphone application versus the reference method

    Time frame: Day of surgery

    Comparison of values to invasive reference method (arterial line)

Secondary outcomes

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

    Time frame: Day of surgery

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

  2. Usability assessment

    Time frame: Day of surgery

    Identification of possible use error in the manipulation of the device and in the performance of the measure

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 8, 2019
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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