NCT02447471

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

8 months

First QC Date

May 14, 2015

Last Update Submit

January 22, 2016

Conditions

Blood Pressure Measurement

Outcome Measures

Primary Outcomes (1)

  • Nexfin bp vs NIBP

    During cesarean delivery

Study Arms (1)

study group

all participants

Device: Nexfin

Interventions

NexfinDEVICE

Nexfin cuff placed on finger to measure blood pressure

study group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

BC Women's hospital parturients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Study Officials

  • Vit Gunka, MD FRCPC

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 18, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

CA(1)