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

• Sponsor: University of British Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02447471
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure Measurement	Device: Nexfin

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 Design

• Study Type: Observational
• Actual Enrollment: 10 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Nexfin bp vs NIBP [During cesarean delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BC Women's Hospital	Vancouver	British Columbia	Canada	V6H 3N1

Sponsors and Collaborators

• University of British Columbia

Investigators

• Principal Investigator: Vit Gunka, MD FRCPC, University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of British Columbia
• ClinicalTrials.gov Identifier: NCT02447471
• Other Study ID Numbers: H15-00992
• First Posted: May 18, 2015
• Last Update Posted: Jan 26, 2016
• Last Verified: Jan 1, 2016

Study Results

No Results Posted as of Jan 26, 2016