Arm and Ankle Blood Pressure Cuffs During C-Section

NCT04934995 | Completed

• 1 other identifier: 2020H0502
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Supine Hypotensive Syndrome; Cesarean Section Complications; Anesthesia Complication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

• 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

Study Arms (1)

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

Interventions

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.

Study Population

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant women will be included in this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (4)

• 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.

  PMID: 20455872 BACKGROUND

• 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.

  PMID: 12032019 BACKGROUND

• 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.

  PMID: 17667564 BACKGROUND

• 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 Sep;64:109796. doi: 10.1016/j.jclinane.2020.109796. Epub 2020 Apr 16.

  PMID: 32305794 BACKGROUND

Study Officials

• Ling-Qun Hu, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: June 22, 2021
• Study Start: March 14, 2021
• Primary Completion: October 20, 2024
• Study Completion: October 20, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

US (1)