Evaluation of Novel Optical Smartphone Application for Bl... | NCT04728477

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

NCT04728477

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Nov 19, 2021Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Hypotension

Interventions

OPti BP measurements

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 3, 2021Actual

Primary Completion Date

Apr 1, 2021Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

Jan 24, 2021

First Submission Date that Met QC Criteria

Jan 24, 2021

First Posted Date

Jan 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2021

Last Update Posted Date

Nov 19, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexandre Joosten, MD PhD, Study Director, Erasme University HospitalPrincipal Investigator

Lead Sponsor

Erasme University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OPti BP measurements	Device	measurement of blood pressure with the new smartphone App ( OPTIBP)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of blood pressure between the new smartphone App and the radial arterial line	Comparative blood pressure measurement with the investigational device and the invasive reference method (arterial line).	48 hours

Secondary Outcomes

Measure	Description	Time Frame
Usability assessment	Identification of possible use error in the manipulation of the device and in the performance of the measure	at 48 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

All intensive care unit patients with an arterial catheter for at least 48 hours

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre JOOSTEN, MD PhD	ERASME	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ERASME		Brussels		1070	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35971072	Derived	Desebbe O, Anas C, Alexander B, Kouz K, Knebel JF, Schoettker P, Creteur J, Vincent JL, Joosten A. Evaluation of a novel optical smartphone blood pressure application: a method comparison study against invasive arterial blood pressure monitoring in intensive care unit patients. BMC Anesthesiol. 2022 Aug 15;22(1):259. doi: 10.1186/s12871-022-01797-0.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases