Arm and Ankle Blood Pressure Cuffs During C-Section

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934995
• Other study ID #: 2020H0502
• Status: Recruiting
• Start date: March 14, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Ohio State University
• Contact: Ling-Qun Hu, MD
• Phone: 614-293-6302
• Email: LingQun.Hu[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Complication
• Cesarean Section Complications

Intervention

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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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
Secondary	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