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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorThe University of Texas Health Science Center, Houston

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant patients

Procedures expected to last < 2 hours

Open surgical approaches

Minor procedures

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lower-Extremity Perfusion Monitoring

    Other intervention

    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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Prolonged Lithotomy Surgery Cohort1 intervention

Trial outcomes

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

Time frame
Duration of the surgery

Secondary outcomes

1

Postoperative lower-limb symptoms- Pain

Postoperative lower-limb symptoms assessed in the post-anesthesia care unit using the following rating scale range 1 through 5, the higher the better. 1. No sensation (completely numb) 2. Severely reduced sensation 3. Moderately reduced sensation 4. Slightly reduced sensation 5. Normal sensation

Time frame
up to 2 hours
2

Postoperative lower-limb symptoms-Motor

Rated using the following scale (range 1-5), higher is better, 1. No movement (complete paralysis) 2. Severe motor impairment 3. Moderate motor impairment 4. Slight motor impairment 5. Normal movement

Time frame
up to 2 hours post surgery
3

Post-operative Limb symptom- sensation

Using the following scale range 1-5, higher is worst. 1. No pain 2. Mild pain 3. Moderate pain 4. Severe pain 5. Worst possible pain

Time frame
up to 2 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.