Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

Comparative Analysis of the Predictive Performance of Noninvasive Beat-by-Beat Blood Pressure and Flow Measurements at the Lower Extremity Versus the Upper Extremity for Neonatal Outcomes Under Spinal Anesthesia for Elective Cesarean Delivery

This is a single-center, prospective observational study in patients undergoing cesarean delivery under spinal or combined spinal-epidural anesthesia. It compares whether continuous noninvasive hemodynamic measurements from the lower extremity (toe) better predict neonatal outcomes than upper extremity (arm/finger) measurements during spinal-induced hypotension.

Participants receive standard spinal anesthesia and routine blood pressure management, with additional monitoring using the ClearSight™ system at both upper and lower extremities from before spinal anesthesia through delivery.

The primary outcome is a composite of neonatal outcomes (APGAR scores, need for respiratory support, cord gases, and NICU admission). Secondary outcomes include maternal side effects and comfort.

Overall, the study evaluates whether lower-extremity hemodynamic monitoring improves detection of clinically relevant hypotension and prediction of neonatal outcomes compared to traditional arm measurements.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Anesthesia; Blockades Neuromuscular
• Intervention / Treatment: Device: ClearSight

Detailed Description

Enrolled parturients undergoing elective cesarean delivery under spinal anesthesia will participate in this prospective, observational study following informed consent. Standard perioperative care will be maintained, including administration of spinal anesthesia (1.6 mL of 0.75% hyperbaric bupivacaine with fentanyl 10 mcg and morphine 100 mcg), crystalloid co-loading, and a prophylactic phenylephrine infusion. For study purposes, the ClearSight™ system will be applied noninvasively to both the upper and lower extremities, with a finger cuff placed on the ring finger of the arm opposite the intravenous line and a toe cuff placed on the left foot, while a standard oscillometric blood pressure cuff will be placed on the same arm. Continuous beat-by-beat blood pressure and flow measurements will be recorded from 3 minutes prior to spinal anesthesia placement until 3 minutes after neonatal delivery, alongside routine intermittent arm cuff measurements. Intraoperative maternal events and hemodynamic parameters will be documented, and neonatal outcome data-including Apgar scores, need for airway support, and NICU admission-will be extracted from the electronic medical record. No additional interventions beyond standard care will be performed, and all data collected will be used to compare the predictive performance of upper versus lower extremity hemodynamic measurements for neonatal outcomes.

• Study Type: Observational
• Enrollment (Estimated): 327

Contacts and Locations

• Study Contact: Name: Alberto Uribe, MD; Phone Number: 6142933559; Email: alberto.uribe@osumc.edu
• Study Contact Backup: Name: Ling-Qun Hu, MD; Phone Number: 6142936302; Email: LingQun.Hu@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University
      • Contact: Alberto Uribe, MD; Phone Number: 6142933559; Email: alberto.uribe@osumc.edu
      • Contact: Ling-Qun Hu, MD; Phone Number: 6142936302; Email: LingQun.Hu@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The study includes adults, children, English- or Spanish-speaking individuals, and pregnant women (and their fetuses). It excludes adults with impaired decision-making capacity, nonviable neonates, neonates of uncertain viability, and prisoners. Eligible participants must be ≥18 years old, able to provide consent in English or Spanish, and have a singleton pregnancy at ≥37 weeks gestation. Exclusion criteria include documented fetal anomalies, congenital malformations, or genetic conditions; unstable cardiac disease (other than hypertensive disorders of pregnancy) that may affect blood pressure; and intrauterine growth restriction. Prisoners and other vulnerable populations are excluded.

Description

Inclusion Criteria:

• Age ≥ 18 years old
• Singleton pregnancy
• Gestational age ≥ 37 weeks
• Women undergoing CD under SAB or Combined Spinal-Epidural (CSE) electively.
• Ability to consent in English and in Spanish language

Exclusion Criteria:

• CD under or converted to general anesthesia
• CD under epidural anesthesia or converted to epidural anesthesia
• Diabetes Mellitus (DM)/Gestational Diabetes Mellitus (GDM)
• Evidence of unstable cardiac disease other than HDP (including chronic hypertension, gestational hypertension, preeclampsia-eclampsia, and chronic hypertension with superimposed preeclampsia) judged by the investigator to have any impact on BP will make the subject unsuitable for participation in the study
• Documented fetal anomaly/ congenital malformations and genetic syndromes
• Intrauterine growth retardation
• Unable to consent in English/Spanish.
• Prisoners

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant Women undergoing Cesarean Delivery	Device: ClearSight; The ClearSight system provides continuous blood pressure and advanced hemodynamic parameters from a noninvasive finger cuff sensor. Therefore, placing both cuff sensors in different arms will ensure no interference with the ClearSight readings due to the conventional blood pressure cuff inflation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidences of FAAAN composite poor neonatal outcomes	FAAAN is a composite neonatal outcome measure used in this study to capture clinically relevant indicators of neonatal well-being and immediate post-delivery support needs. It includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), and NICU admission. The primary outcome is the incidence of a composite of poor neonatal outcomes, referred to as FAAAN. This composite includes abnormal fetal heart rate patterns, Apgar scores at 1 and 5 minutes, requirement for fetal airway support (mask ventilation, supplemental oxygen, CPAP, or intubation), NICU admission, cord blood gas abnormalities, and delayed cord clamping.	24 Hours after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Maternal nausea/vomiting, arm, finger, and toe comfort, and shivering	24 Hours after delivery

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2025
• Primary Completion (Estimated): February 6, 2029
• Study Completion (Estimated): August 6, 2029

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024H0319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No