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OpenTrials
Completed

NCT Number: NCT02933541

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.

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Key information

Conditions

Central Blood Pressures

Age range

14 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

St. Mary's Health Center

St Louis, Missouri, 63117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Amount of change in central arterial pressure in obesity.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2016
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.