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

Blood Pressure Measurement Clinical Trial

— Nexfin Pilot  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447471
• Other study ID #: H15-00992
• Status: Completed
• Phase: N/A
• First received: May 14, 2015
• Last updated: January 22, 2016
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure Measurement

Intervention

Device:
• Nexfin
Nexfin cuff placed on finger to measure blood pressure

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nexfin bp vs NIBP		During cesarean delivery