RecruitingNCT07387653

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

30 participants

Start Date

Jan 29, 2026

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALE

Inclusion Criteria4

  • 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

Exclusion Criteria6

  • 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)

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Interventions

OTHERLower-Extremity Perfusion Monitoring

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


Locations(2)

Memorial Hermann Medical Center

Houston, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

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NCT07387653


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