Agreement of the Nexfin™ Monitor With Non-invasive Blood... | NCT02447471

Studies
Agreement of the Nexfin™ Monitor With Non-invasive Blood Pressure Measurement

NCT02447471

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Jan 26, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Blood Pressure Measurement

Interventions

Nexfin

Countries

Canada

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

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

May 2015

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

May 14, 2015

First Submission Date that Met QC Criteria

May 14, 2015

First Posted Date

May 18, 2015Estimated

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

Jan 22, 2016

Last Update Posted Date

Jan 26, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Currently, BP is measured using an inflatable cuff wrapped around the patient's upper arm. This can be set to inflate every minute, but measurement may fail due to patient movement or shivering. Failed measurement occurs in up to 38% of patients.

This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.

Detailed Description

This study aims to determine how the Nexfin device - which measures BP using a cuff wrapped around a finger - compares to standard BP measurement.

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group		all participants	Device: Nexfin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nexfin	Device	Nexfin cuff placed on finger to measure blood pressure	study group

Measure	Description	Time Frame
Nexfin bp vs NIBP		During cesarean delivery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy female pregnant patients
≥19 years old
Undergoing elective Cesarean section under spinal or combined spinal-epidural anesthesia

Exclusion Criteria:

Contraindication to wearing Nexfin cuff (upper limb vascular disease, amputated digits)
Obesity (BMI > 38 kg/m2)
Use of arterial line for BP measurement
Inability to read and understand English

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

BC Women's hospital parturients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vit Gunka, MD FRCPC	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BC Women's Hospital		Vancouver	British Columbia	V6H 3N1	Canada

Type	Date	Date Unknown
Release	Apr 27, 2017
Reset	Aug 4, 2017