Agreement and Precision of a Smartphone Application For C... | NCT04119193

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

NCT04119193

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Dec 11, 2019Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Technology

Interventions

Novel smartphone application for blood pressure measurement

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

Dec 2019

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

Nov 12, 2019Actual

Primary Completion Date

Dec 8, 2019Actual

Completion Date

Dec 8, 2019Actual

First Submitted Date

Oct 5, 2019

First Submission Date that Met QC Criteria

Oct 5, 2019

First Posted Date

Oct 8, 2019Actual

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

Dec 10, 2019

Last Update Posted Date

Dec 11, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexandre Joosten, MD PhD, Principal Investigator, 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 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.

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.

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
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of blood pressure measurement done with the novel smartphone application versus the reference method	Comparison of values to invasive reference method (arterial line)	Day of surgery

Secondary Outcomes

Measure	Description	Time Frame
Number of necessary measure to have a good relationship between both methods	Number of necessary measure to have a good relationship between both methods	Day of surgery
Usability assessment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre J Joosten, MD PhD	ERASME	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasme		Brussels		1070	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001795	Blood Pressure Determination

Ancestor Terms

ID	Term
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D010808	Physical Examination

Browse Leaves

Not provided

Browse Branches

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