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Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight
Sponsor: Ohio State University
Summary
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
327
Start Date
2025-02-06
Completion Date
2029-08-06
Last Updated
2026-07-06
Healthy Volunteers
Yes
Interventions
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.
Locations (1)
The Ohio State University
Columbus, Ohio, United States