NCT07387653 · The University of Texas Health Science Center, Houston
Feasibility and Clinical Utility of Paired Non-Invasive Hemodynamic and Tissue Oximetry Monitoring to Detect Limb Ischemia in Lithotomy-Positioned Surgeries
(LIMB)
What this study is about
The LIMB Study is a forward-looking, 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.
View original scientific description
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.
Interventions
OTHER
Lower-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
Primary outcome measures
StO₂ desaturation episodes
Time frame: Duration of the surgery
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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)
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations