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

Conditions

• Limb Ischemia
• Neuropathy;Peripheral

Eligibility Criteria

Sex

FEMALE

Age

N/A - N/A

Healthy Volunteers

Accepted

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

Study Details

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

Key Dates

Start date

Jan 29, 2026

Status verified

May 2026

Primary completion

Jun 30, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

30 participants (estimated)

Arms

• Arm: Prolonged Lithotomy Surgery Cohort
  Prolonged Lithotomy Surgery Cohort

Primary Outcome Measure

StO₂ desaturation episodes [ Time Frame: Duration of the surgery ]

Central Contacts

• Randa Jalloul, MD, MS
  7134867700
  [email protected]

Locations (2)

Find similar trials in Houston, TX

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