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.
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.
United States2 sites, 2 recruiting
- Not yet recruiting
Memorial Hermann Medical Center
Houston, Texas, 77027
Randa Jalloul, MD, MS, 7134867700, randa.j.jalloul@uth.tmc.edu
- Recruiting
Memorial Hermann Hospital
Houston, Texas, 77401
Randa Jalloul, MD, (713) 486-7700, randa.j.jalloul@uth.tmc.edu
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.
- Conditions
- Neuropathy;Peripheral, Limb Ischemia
- 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 group | Role | What they receive |
|---|---|---|
| Prolonged Lithotomy Surgery Cohort | Prolonged 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.
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)
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.
- No sensation (completely numb)
- Severely reduced sensation
- Moderately reduced sensation
- Slightly reduced sensation
- Normal sensation
Measured: up to 2 hours
Postoperative lower-limb symptoms-Motor
Rated using the following scale (range 1-5), higher is better,
- No movement (complete paralysis)
- Severe motor impairment
- Moderate motor impairment
- Slight motor impairment
- Normal movement
Measured: up to 2 hours post surgery
Post-operative Limb symptom- sensation
Using the following scale range 1-5, higher is worst.
- No pain
- Mild pain
- Moderate pain
- Severe pain
- 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.
- First posted4 Feb 2026
- Study start29 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathy;PeripheralStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Jalloul, The University of Texas Health Science Center, Houston
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Clinical Utility of Paired Non-Invasive Hemodynamic and Tissue Oximetry Monitoring to Detect Limb Ischemia in Lithotomy-Positioned Surgeries
- ClinicalTrials.gov ID
- NCT07387653
- Acronym / sponsor ID
- LIMB / HSC-MS-25-0372
- Conditions
- Neuropathy;Peripheral, Limb Ischemia
- Keywords
- trendelemberg, nerve injury, position nerve injury, prolonged surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged Lithotomy Surgery Cohort | – | Other: Lower-Extremity Perfusion MonitoringProlonged Lithotomy Surgery Cohort |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Pregnant patients
- Procedures expected to last < 2 hours
- Open surgical approaches
- Minor procedures
- Known allergy or sensitivity to adhesives used for monitoring sensors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower-Extremity Perfusion MonitoringThis 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 | Other | Prolonged Lithotomy Surgery Cohort |
Primary outcome
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
3 secondary outcomes
Postoperative lower-limb symptoms- Pain
Time frame: up to 2 hours
Postoperative lower-limb symptoms-Motor
Time frame: up to 2 hours post surgery
Post-operative Limb symptom- sensation
Time frame: up to 2 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
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.