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

Completed

• Conditions: Central Blood Pressures

• Registration Number: NCT02933541
• Lead Sponsor: St. Louis University

Brief Summary

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

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-14
• Primary Completion: 2023-10-19
• Study Completion: 2023-10-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of change in central arterial pressure in obesity.	3 hours	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.

Trial Locations

Locations (1)

St. Mary's Health Center; 🇺🇸 Saint Louis, Missouri, United States