Agreement of the Nexfin™ Monitor With Non-invasive Blood Pressure Measurement (Nexfin Pilot)

January 22, 2016 updated by: University of British Columbia

Agreement of the Nexfin™ Non-invasive Cardiac Output Monitor With Non-invasive Blood Pressure Measurement in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia: a Pilot Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • BC Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

BC Women's hospital parturients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
all participants
Device: Nexfin
Nexfin cuff placed on finger to measure blood pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nexfin bp vs NIBP
Time Frame: During cesarean delivery
During cesarean delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • H15-00992

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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