Upper vs Lower Extremity BP in Spinal Cesarean Using ClearSight

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07685730
Status
Recruiting
Apply to this trial

Conditions

  • Anesthesia
  • Blockades Neuromuscular
  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ClearSight — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 6, 2025
Status verified
Jun 2026
Primary completion
Feb 6, 2029
Completion
Aug 6, 2029

Study Design

Enrollment
327 participants (estimated)

Arms

  • Arm: Pregnant Women undergoing Cesarean Delivery

Primary Outcome Measure

Incidences of FAAAN composite poor neonatal outcomes [ Time Frame: 24 Hours after delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Alberto Uribe, MD
[email protected]
6142933559
Ling-Qun Hu, MD
[email protected]
6142936302

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By research site
The Ohio State University· Columbus, OH

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