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

NCT ID: NCT02933541

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2023-10-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Central Blood Pressures

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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St. Louis University

OTHER

Sponsor Role lead

Responsible Party

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Niraj R. Chavan, MD, MPH

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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St. Mary's Health Center

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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27440

Identifier Type: -

Identifier Source: org_study_id

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