Wrist NIBP During Elective Cesarean Delivery

NCT01677234 | Completed

• 1 other identifier: H12-01797
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Blood pressure is typically measured with a non-invasive cuff placed on the upper arm. This cuff cannot take accurate measurements when the patient's arm is moving. Anesthesia for a cesarean delivery frequently causes the patient to shiver and their arm to shake, and sometimes to the extent that blood pressure cannot be measured. A cuff placed on the wrist may be more effective when a patient is shivering because their lower arm moves less and can be more easily stabilized. We will be taking simultaneous blood pressure measurements both just before and during cesarean deliveries in order to compare blood pressure at the upper arm versus the wrist.

Conditions

Wrist Blood Pressure Measurements; Anesthesia Resulting in Shivering

Keywords

Blood pressure

Outcome Measures

Primary Outcomes (1)

• Compare trends in NIBP measurements between the upper arm and forearm

  Measure NIBP at the upper arm and forearm simultaneously during surgery. NIBP cuffs will be on opposite arms.

  30 minutes

Secondary Outcomes (1)

• To estimate the accuracy of blood pressure measured on the forearm

  30 minutes

Study Arms (1)

Pregnant women

Pregnant women undergoing a cesarean section

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women having an elective cesarean delivery at BC Women's Hospital in Vancouver, British Columbia.

You may qualify if:

• Healthy (American Society of Anesthesiologist's (ASA) physical status I or II) patients
• Having an elective cesarean delivery under spinal or combined spinal epidural anesthesia
• ≥19 years old

You may not qualify if:

• Contra-indication to neuraxial anesthesia
• General anesthesia for any reason prior to delivery of the baby
• Use of the epidural component (epidural top-up) of combined spinal epidural anesthesia (prior to delivery of the baby)
• History of cardiovascular disease, e.g. hypertension (either essential or pregnancy-induced)
• A difference of more than 10% between both upper arms and forearms in mean blood pressure measurement prior to surgery (see below)
• BMI \>35kg/m2 (it is more difficult to ensure the cuff size is correct in these obese patients)
• Inability to read and understand English for the purpose of informed consent

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia's Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Study Officials

• Simon Massey, MD

  University of British Columbia, BC Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: August 31, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

CA (1)