Central Arterial Pressure Changes With Use of Regional Anesthesia in Obstetric Patients

Plan to monitor central arterial pressure in women who are undergoing spinal anesthesia for cesarean delivery or epidural anesthesia for vaginal delivery.

Study Overview

• Status: Completed
• Conditions: Central Blood Pressures

Detailed Description

Subjects will be screened as they are admitted to the maternity care floor (5th floor St. Mary's Hospital). Subjects will be approached if they are desiring regional anesthesia.

The subject will have an additional blood pressure cuff placed on the arm that anesthesia is not using for their blood pressure cuff. Central arterial pressure will be measured from the cuff:

• Prior to regional anesthesia placement
• Every 15 minutes for 1 hour
• Every 30 minutes for 2 hours Routine sphygmomanometer measurements will also completed at the above times. These are all study procedures.

Anesthesia will use their usual protocol for blood pressure monitoring and management during placement of, and after the procedure. No changes in patient management will be made based upon the central arterial pressure as the guidelines were developed with routine brachial pressure.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • St. Mary's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Women who are admitted to our obstetrics ward and are planning on receiving regional anesthesia will be approached.

Description

Inclusion Criteria:

• Singleton pregnancy
• Planned regional anesthesia

Exclusion Criteria:

• Multiple pregnancy
• Emergent cesarean delivery
• Irregular heart rhythms or arrhythmias
• Peripheral arterial disease, leg artery disease
• Reynaud's phenomena
• Intense cold/hypothermia
• If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
• Severe tachycardia (>120)
• Greater than 1st degree heart block
• Congestive heart failure or heart disease
• Inability to adequately monitor BP
• Use of magnesium sulfate

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of change in central arterial pressure in obesity.	To determine if women who are obese undergo a larger change in their central arterial pressure than is seen by routine brachial cuff assessment, and if this effect is dependent on the level of obesity.	3 hours

Collaborators and Investigators

• Sponsor: St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimated): October 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 27440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No