Clinical trial NCT04934995: Arm and Ankle Blood Pressure Cuffs During C-Section
Official title: Comparison of Arm and Ankle Blood Pressure During Cesarean Delivery: A Blood Pressure Cuffs Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supine Hypotensive Syndrome
Cesarean Section Complications
Anesthesia Complication
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing cesarean delivery (CD) at The Ohio State University Wexner Medical Center

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference of SBP measured between arm and ankle during elective CD before SAB
timeFrame: Immediately before subarachnoid anesthesia block (after standard of care left uterine displacement maneuver is performed).
measure: Difference of SBP measured between arm and ankle during elective CD after SAB (before incision)
timeFrame: Immediately after subarachnoid anesthesia block is completed
Secondary outcomes:
measure: Incidence of intraoperative nausea in our patient population
timeFrame: Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge
measure: Incidence of intraoperative vomiting in our patient population
timeFrame: Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ling-Qun Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.