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Feasibility and Clinical Utility of Paired Non-Invasive Hemodynamic and Tissue Oximetry Monitoring to Detect Limb Ischemia in Lithotomy-Positioned Surgeries

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The LIMB Study is a prospective, observational pilot study evaluating the feasibility of combined non-invasive hemodynamic and lower-limb tissue oximetry monitoring during prolonged minimally invasive pelvic surgeries performed in lithotomy position. Thirty patients will undergo continuous intraoperative monitoring, with the primary outcome being the frequency and duration of tissue oxygen desaturation events and secondary outcomes examining correlations with postoperative limb pain, sensation, and motor function. The study is non-interventional, poses minimal risk, and aims to generate preliminary data to inform future strategies for early detection and prevention of limb ischemia and well-leg compartment syndrome

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• Adult patients

• Undergoing minimally invasive pelvic surgery (such as hysterectomy, myomectomy, or endometriosis surgery)

• Surgery performed in lithotomy position

• Expected surgical duration \> 2 hours as determined by the primary surgeon

Locations
United States
Texas
Memorial Hermann Hospital
RECRUITING
Houston
Memorial Hermann Medical Center
NOT_YET_RECRUITING
Houston
Contact Information
Primary
Randa Jalloul, MD, MS
randa.j.jalloul@uth.tmc.edu
7134867700
Time Frame
Start Date: 2026-01-29
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Prolonged Lithotomy Surgery Cohort
Prolonged Lithotomy Surgery Cohort
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston

This content was sourced from clinicaltrials.gov