Arm and Ankle Blood Pressure Cuffs During C-Section

Completed

• Conditions: Supine Hypotensive Syndrome; Cesarean Section Complications; Anesthesia Complication
• Interventions: Other: Blood Pressure Cuff

• Registration Number: NCT04934995
• Lead Sponsor: Ohio State University

Brief Summary

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

Detailed Description

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:

1. Poor placental perfusion from inadequate LUD due to the potential impact of supine hypotensive syndrome (SHS) secondary to aortocaval compression especially after SAB;

2. 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;

3. 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.

Study Timeline

• Study Start: 2021-03-14
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-22
• Primary Completion: 2024-10-20
• Study Completion: 2024-10-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

1. 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)
2. Prisoners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Population	Blood Pressure Cuff	Adult women undergoing cesarean delivery at The Ohio State University Wexner Medical Center under spinal anesthesia, ASA physical status I-III with a BMI during pregnancy ≥ 35 kg/m2 and singleton pregnancy.

Primary Outcome Measures

Name	Time	Method
Difference of SBP measured between arm and ankle during elective CD before SAB	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).
Difference of SBP measured between arm and ankle during elective CD after SAB (before incision)	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 Outcome Measures

Name	Time	Method
Incidence of intraoperative vomiting in our patient population	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
Incidence of intraoperative nausea in our patient population	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

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States