Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07387653

Conditions

Neuropathy;Peripheral

Limb Ischemia

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Lower-Extremity Perfusion Monitoring

Study Details

Brief 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

Conditions

Neuropathy;Peripheral

Limb Ischemia

Study ID

NCT07387653

Start date

Jan 29, 2026

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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:

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)

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Prolonged Lithotomy Surgery Cohort

Prolonged Lithotomy Surgery Cohort

Interventions

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 measure

  • StO₂ desaturation episodes [ Time Frame: Duration of the surgery ]

Central Contacts and Locations

Central contacts

Randa Jalloul, MD, MS

7134867700randa.j.jalloul@uth.tmc.edu

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77401

Contacts

Randa Jalloul, MD

(713) 486-7700randa.j.jalloul@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-05-14.