Arm and Ankle Blood Pressure Cuffs During C-Section

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

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

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section Complications; Anesthesia Complication; Supine Hypotensive Syndrome
• Intervention / Treatment: Other: Blood Pressure Cuff

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ling-Qun Hu, MD; Phone Number: 614-293-6302; Email: LingQun.Hu@osumc.edu
• Study Contact Backup: Name: Alberto Uribe, MD; Phone Number: 614-293-3559; Email: alberto.uribe@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Ling-Qun Hu, MD; Phone Number: 614-293-6302; Email: LingQun.Hu@osumc.edu
      • Contact: Alberto Uribe, MD; Phone Number: 614-293-3559; Email: alberto.uribe@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing cesarean delivery (CD) at The Ohio State University Wexner Medical Center

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study Population; 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.

Other: Blood Pressure Cuff; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of SBP measured between arm and ankle during elective CD before SAB	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).	Immediately before subarachnoid anesthesia block (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)	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	Immediately after subarachnoid anesthesia block is completed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative nausea in our patient population	the incidence of intraoperative nausea will be assessed during anesthesia and surgery	Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge
Incidence of intraoperative vomiting in our patient population	the incidence of intraoperative vomiting will be assessed during anesthesia and surgery	Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Ling-Qun Hu, MD, Ohio State University

Publications and helpful links

General Publications

• Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
• Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
• Hartmann B, Junger A, Klasen J, Benson M, Jost A, Banzhaf A, Hempelmann G. The incidence and risk factors for hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg. 2002 Jun;94(6):1521-9, table of contents. doi: 10.1097/00000539-200206000-00027.
• Chungsamarnyart Y, Wacharasint P, Carvalho B. Hemodynamic profiles with and without left uterine displacement: A randomized study in term pregnancies receiving subarachnoid blockade for cesarean delivery. J Clin Anesth. 2020 Apr 16;64:109796. doi: 10.1016/j.jclinane.2020.109796. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2020H0502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No