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Evaluation of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients

Accuracy, Precision and Trending Abilities of Novel Optical Smartphone Application for Blood Pressure Measurements in Critically Ill Patients: A Method Comparison Study Against the Arterial Line as the Reference Method

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04728477
Enrollment
30
Registered
2021-01-28
Start date
2021-02-03
Completion date
2021-04-01
Last updated
2021-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Brief summary

Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in intensive care unit patients

Detailed description

The purpose of the study is to compare the blood pressure values measured by a novel mobile phone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the radial arterial line) All patients admitted in the intensive care unit at Erasme Hospital Brussels, Belgium will be recruited and if they have an arterial line for at least two days The OptiBP Application is a mobile application installed on a mobile phone which is a non-invasive data-logger intended to acquire physiological data from patients. By applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure. Three measures will be taken (spaced by one minute) with both methods each hour for 5 hours and this will be done for 2 days. The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (arterial line). Then, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the novel mobile application. The goal is therefore to compare blood pressure values as obtained by the analysis of the data recorded by the OptiBP Mobile Application, against simultaneous measurements provided by the arterial line (gold standard)

Interventions

DEVICEOPti BP measurements

measurement of blood pressure with the new smartphone App ( OPTIBP)

Sponsors

Erasme University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* All Intensive care unit patients with an arterial catheter for at least 48 hours * Informed Consent as documented by signature

Exclusion criteria

* Patients or families that cannot sign informed consent * Patients in emergency situation, and unstable * Dyshythmia like bigeminy, trigeminy, isolated Ventricular Premature Beats (VPB), atrial fibrillation * Lesion or deficiency on hand, preventing index obstruction of smartphone's camera * Known contact dermatitis to nickel/chromium

Design outcomes

Primary

MeasureTime frameDescription
Comparison of blood pressure between the new smartphone App and the radial arterial line48 hoursComparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).

Secondary

MeasureTime frameDescription
Usability assessmentat 48 hourIdentification of possible use error in the manipulation of the device and in the performance of the measure

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026