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Neuropathy;PeripheralLIMBNCT07387653

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

An observational study of Neuropathy;Peripheral and Limb Ischemia, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Neuropathy;Peripheral, Limb Ischemia
What is being tested?
Lower-Extremity Perfusion Monitoring
How many people
30 participants
Where
2 sitesUnited States
Study dates
29 Jan 2026to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Randa Jalloul, MD, MS contact

7134867700

randa.j.jalloul@uth.tmc.edu

United States2 sites, 2 recruiting
  • Memorial Hermann Medical Center

    Houston, Texas, 77027

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

    Not yet recruiting
  • Memorial Hermann Hospital

    Houston, Texas, 77401

    Randa Jalloul, MD, (713) 486-7700, randa.j.jalloul@uth.tmc.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
Lower-Extremity Perfusion Monitoring
Keywords
trendelemberg, nerve injury, position nerve injury, prolonged surgery
Medical subject headings
Neuritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lower-Extremity Perfusion MonitoringOther

    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 groups in NCT07387653
Study groupRoleWhat they receive
Prolonged Lithotomy Surgery CohortProlonged Lithotomy Surgery Cohort
Receives: Other: Lower-Extremity Perfusion Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Duration of the surgery

Secondary outcomes (3)
  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

    Measured: 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

    Measured: 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

    Measured: up to 2 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start29 Jan 2026
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07387653
Sponsor's protocol ID
HSC-MS-25-0372
Acronym
LIMB
Status last verified
May 2026
First submitted
27 Jan 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neuropathy;Peripheral and Limb Ischemia, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Randa Jalloul, MD, MS (7134867700, randa.j.jalloul@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

StO₂ desaturation episodes (time frame: Duration of the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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