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RecruitingNCT07387653LIMBUpdated May 14, 2026

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

An observational study in Neuropathy;Peripheral and Limb Ischemia, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 2 sites in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by The University of Texas Health Science Center, Houston · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Sex
Female
01

Study 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

Read the detailed description

Well-leg compartment syndrome (WLCS) is a rare but potentially devastating complication associated with prolonged surgical procedures performed in the lithotomy position. Prolonged limb elevation, external compression, and reduced perfusion pressure can lead to muscle ischemia, nerve injury, and long-term functional impairment. Early clinical detection of limb ischemia is challenging in anesthetized patients, as classic signs and symptoms often present late in the disease course. As a result, subclinical ischemic events may go unrecognized until postoperative neurologic or motor deficits are identified.

Near-infrared spectroscopy (NIRS)-based tissue oximetry and continuous non-invasive hemodynamic monitoring have emerged as promising technologies for early detection of tissue hypoperfusion. The Edwards Acumen IQ non-invasive hemodynamic monitoring system provides continuous beat-to-beat blood pressure and derived cardiovascular parameters, while the ForeSight IQ tissue oximetry system provides absolute tissue oxygen saturation (StO₂) measurements without the need for a baseline calibration. These systems are FDA-cleared and currently used in clinical settings such as extracorporeal membrane oxygenation (ECMO), where reductions in tissue oxygenation have been shown to correlate with limb ischemia.

This prospective, observational pilot study is designed to evaluate the feasibility and clinical utility of combining continuous non-invasive hemodynamic monitoring with bilateral lower-extremity tissue oximetry in patients undergoing prolonged minimally invasive pelvic surgery in the lithotomy position. The study is non-interventional, and no changes to intraoperative or postoperative clinical management will be made based on monitoring data.

A total of 30 adult patients undergoing minimally invasive hysterectomy, myomectomy, or endometriosis surgery in lithotomy position with an anticipated operative duration greater than two hours will be enrolled at a single academic medical center. Patients who are pregnant, undergoing open procedures, expected to have surgery lasting less than two hours, or who have a known allergy to medical adhesives will be excluded. No vulnerable populations will be enrolled.

After informed consent is obtained in the preoperative area, patients will undergo standard anesthesia and surgical care. Following induction of anesthesia, bilateral ForeSight IQ tissue oximetry sensors will be placed longitudinally over the medial calf muscles, and an Acumen IQ finger cuff will be applied for continuous non-invasive hemodynamic monitoring. Devices will be calibrated, and baseline hemodynamic and tissue oxygenation values will be recorded prior to surgical positioning. Continuous monitoring will be maintained throughout the intraoperative period.

The primary outcome is the occurrence and duration of intraoperative lower-extremity tissue oxygen desaturation events, defined as either a greater than 15% decrease from baseline StO₂ or an absolute StO₂ value below 50% sustained for more than five minutes. These events will be recorded retrospectively from device output and analyzed descriptively.

Secondary outcomes include the correlation between intraoperative tissue oxygenation changes and postoperative lower-extremity symptoms. In the post-anesthesia care unit (PACU), patients will complete a brief standardized assessment rating limb sensation, pain, and motor function on a 5-point Likert scale prior to discharge. The electronic medical record will be reviewed for up to 30 days postoperatively to identify any documented neurologic or musculoskeletal complications related to lower-extremity perfusion.

Demographic data, surgical characteristics, and known risk factors for limb ischemia will be collected from the electronic health record and stored in a secure REDCap database. Data will be de-identified for analysis, with linkage logs stored separately and securely.

As this is an observational feasibility study, no direct clinical benefit is expected for participants. Risks are minimal and primarily related to potential skin irritation from adhesive sensors. No study-related interventions are performed. Study findings may inform future protocols aimed at early detection and prevention of limb ischemia during prolonged surgeries in lithotomy position.

02

Conditions studied

  • Neuropathy;Peripheral
  • Limb Ischemia

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Keywords

  • trendelemberg
  • nerve injury
  • position nerve injury
  • prolonged surgery
03

In context

Neuritis

73 studies on the registry are indexed under Neuritis; 20 are open to participants now.

This study's planned enrollment of 30 is below the median of 123 across 20 observational studies indexed under Neuritis.

Browse Neuritis studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult patients
  2. Undergoing minimally invasive pelvic surgery (such as hysterectomy, myomectomy, or endometriosis surgery)
  3. Surgery performed in lithotomy position
  4. Expected surgical duration > 2 hours as determined by the primary surgeon

Exclusion criteria

Exclusion Criteria:

  1. Pregnant patients
  2. Procedures expected to last \< 2 hours
  3. Open surgical approaches
  4. Minor procedures
  5. Known allergy or sensitivity to adhesives used for monitoring sensors
  6. Vulnerable populations (incarcerated, elderly or pregnant)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Prolonged Lithotomy Surgery Cohort

    Prolonged Lithotomy Surgery Cohort

    Other: Lower-Extremity Perfusion Monitoring

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

06

What researchers measure

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

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Study locations

1 of 2 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07387653
Responsible party
Randa Jalloul (Associate Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Feb 4, 2026
Start date
Jan 29, 2026
Primary completion
Jun 30, 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 14, 2026

Study contacts

Randa Jalloul, MD, MS
Contact
randa.j.jalloul@uth.tmc.edu
7134867700

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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