Arm and Ankle Blood Pressure Cuffs During C-Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-14

Study Completion Date

2024-10-20

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Supine Hypotensive Syndrome Cesarean Section Complications Anesthesia Complication

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood Pressure Cuff

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No