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CompletedNCT04119193Updated Dec 11, 2019

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

An observational study in Technology, sponsored by Erasme University Hospital. Completed at 1 site in Belgium. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Erasme University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Technology
03

In context

Lead sponsor

Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • DeviceNovel 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.

06

What researchers measure

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)

    Time frame: Day of surgery

Secondary outcomes

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

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

    Time frame: Day of surgery

  2. Usability assessment

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

    Time frame: Day of surgery

07

Study locations

1 site
  • Erasme
    Brussels, 1070, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04119193
Lead sponsor
Erasme University Hospital
Responsible party
Alexandre Joosten, MD PhD (Principal Investigator, Erasme University Hospital) — Principal investigator
First posted
Oct 8, 2019
Start date
Nov 12, 2019
Primary completion
Dec 8, 2019
Completion
Dec 8, 2019
Last update
Dec 11, 2019

Study contacts

Alexandre J Joosten, MD PhD
principal investigator · ERASME

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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