Skip to main content
OpenTrials
Completed

NCT Number: NCT04934995

Arm and Ankle Blood Pressure Cuffs During C-Section

This is a single center prospective self-control study to validate the effectiveness of left uterine displacement after subarachnoid block (SAB) with simultaneous measurements of blood pressure (BP) on the arm and left ankle during surgery in patients undergoing cesarean delivery (CD) at The Ohio State University Wexner Medical Center

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Supine Hypotensive Syndrome Anesthesia Complication Cesarean Section Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

In the last three decades, numerous interventions have been studied and implemented into our daily practice, such as pre-loading versus co-loading, phenylephrine versus ephedrine, and phenylephrine infusion versus intermittent boluses. In addition, the effectiveness of left uterine displacement (LUD) to improve blood flow and pressure remains unclear. Also, there are issues to be addressed on this regard, including:

  • Poor placental perfusion from inadequate LUD due to the potential impact of supine hypotensive syndrome (SHS) secondary to aortocaval compression especially after SAB;
  • Shivering during cesarean delivery (CD) resulting in inaccurate BP measurements, the incidence of shivering during CD is reported to be 21.9%. It is unclear the impact of shivering during CD on blood pressure (BP) measurements;
  • Patient discomfort during BP measurements, calf > arm > ankle

The Investigators are conducting a single center prospective self-control study aiming to validate the effectiveness of LUD after SAB with simultaneous measurements of BP on the arm and left ankle during surgery in patients undergoing cesarean delivery (CD). In addition, the Investigators will determine whether ankle BP correlates more accurately than arm SBP with the incidence of nausea/vomiting and category II or III fetal heart tracing and bradycardia after SAB and LUD under no shivering conditions and the impact of body mass index and antepartum estimation of newborn weight on SHS after the SAB.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old
  • Women undergoing cesarean delivery at The Ohio State University Wexner Medical Center under spinal anesthesia
  • American Society of Anesthesiologists Physical Status I-III
  • Body mass index during pregnancy ≥ 35 kg/m2
  • Able to consent in English language
  • Singleton pregnancy

Exclusion criteria

  • Women undergoing elective cesarean delivery at The Ohio State University Wexner Medical Center under anesthesia other than spinal anesthesia (i.e. general and/or epidural anesthesia)
  • Prisoners

Treatment and study plan

Blood Pressure Cuff

Other

After obtaining consent and confirming eligibility, Blood Pressure cuffs will be used as specified below:

Cuff size: large BP cuffs will be the default size for both arm and ankle measurements, but can be changed as clinically indicated based on circumferences of limbs Cuff location: BP cuffs will be placed on the contralateral arm to the main peripheral IV following standard procedures. Left ankle cuff will be placed underneath intermittent pneumatic compression cuffs Ankle blood pressure monitor screen will be covered. Thus, anesthesia providers will not be able to make any clinical decisions based on ankle blood pressures but arm blood pressure (standard) instead.

Primary outcomes

  1. Difference of SBP measured between arm and ankle during elective CD before SAB

    Time frame: Immediately before subarachnoid anesthesia block (after standard of care left uterine displacement maneuver is performed).

    Arm Systolic Blood Pressure values will be compared with the ankle SBP values before subarachnoid anesthesia. Baseline SBP will be measured pre-spinal anesthesia in supine position (after standard of care left uterine displacement maneuver is performed).

  2. Difference of SBP measured between arm and ankle during elective CD after SAB (before incision)

    Time frame: Immediately after subarachnoid anesthesia block is completed

    Arm Systolic Blood Pressure values will be compared with the ankle SBP values after subarachnoid anesthesia. Postspinal SBP will be measured in supine position, after LUD is performed

Secondary outcomes

  1. Incidence of intraoperative nausea in our patient population

    Time frame: Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge

    the incidence of intraoperative nausea will be assessed during anesthesia and surgery

  2. Incidence of intraoperative vomiting in our patient population

    Time frame: Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge

    the incidence of intraoperative vomiting will be assessed during anesthesia and surgery

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Comparison of Arm and Ankle Blood Pressure During Cesarean Delivery: A Blood Pressure Cuffs Pilot Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2021
Registry last updated
Nov 21, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.