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

NCT07387653 | Not Yet Recruiting

• 1 other identifier: HSC-MS-25-0372
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Limb Ischemia; Neuropathy;Peripheral

Keywords

trendelemberg; nerve injury; position nerve injury; prolonged surgery

Outcome Measures

Primary Outcomes (1)

• StO₂ desaturation episodes

  Intraoperative lower-limb tissue oxygenation events, defined as the number and duration of StO₂ desaturation episodes, including a drop \>15% from baseline or an absolute StO₂ \<50% lasting more than 5 minutes, recorded continuously during surgery

  Duration of the surgery

Secondary Outcomes (3)

• Postoperative lower-limb symptoms- Pain

  up to 2 hours

• Postoperative lower-limb symptoms-Motor

  up to 2 hours post surgery

• Post-operative Limb symptom- sensation

  up to 2 hours after surgery

Study Arms (1)

Prolonged Lithotomy Surgery Cohort

Prolonged Lithotomy Surgery Cohort

Other: Lower-Extremity Perfusion Monitoring

Interventions

Lower-Extremity Perfusion Monitoring OTHER

This study involves non-interventional physiologic monitoring only, with no alteration to standard surgical or anesthetic care. After induction of anesthesia, patients will have a non-invasive finger cuff applied for continuous beat-to-beat blood pressure and hemodynamic monitoring, along with bilateral lower-leg tissue oximetry sensors placed over the medial calf to continuously measure tissue oxygen saturation (StO₂) throughout surgery. The monitoring data are recorded for observational analysis only, and postoperative limb pain, sensation, and motor function are assessed once in the recovery unit using standardized 5-point Likert scales

Prolonged Lithotomy Surgery Cohort

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 30 adult patients undergoing minimally invasive pelvic surgery-including hysterectomy, myomectomy, or endometriosis surgery-performed in the lithotomy position at a single tertiary care center. Eligible patients are those whose procedures are expected to last longer than two hours, placing them at potential risk for lower-limb ischemia related to prolonged positioning. This cohort represents a typical gynecologic surgical population without inclusion of pregnant or other vulnerable individuals

You may qualify if:

• 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

You may not qualify if:

• Pregnant patients
• Procedures expected to last \< 2 hours
• Open surgical approaches
• Minor procedures
• Known allergy or sensitivity to adhesives used for monitoring sensors
• Vulnerable populations (incarcerated, elderly or pregnant)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Medical Center

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Neuritis

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Randa Jalloul, MD, MS

CONTACT

7134867700; randa.j.jalloul@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)