Actively Recruiting
Feasibility and Clinical Utility of Paired Non-Invasive Hemodynamic and Tissue Oximetry Monitoring to Detect Limb Ischemia in Lithotomy-Positioned Surgeries
Led by The University of Texas Health Science Center, Houston · Updated on 2026-05-14
30
Participants Needed
2
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility and usefulness of combining non-invasive hemodynamic and tissue oxygen monitoring during prolonged minimally invasive pelvic surgeries performed with patients in the lithotomy position. The study focuses on detecting limb ischemia and well-leg compartment syndrome, rare but serious complications that can cause muscle and nerve damage due to reduced blood flow during surgery. It is an observational pilot study involving 30 adult patients undergoing procedures like hysterectomy, myomectomy, or endometriosis surgery lasting more than two hours. Patients will receive continuous monitoring during surgery using FDA-cleared devices: the Edwards Acumen IQ system for beat-to-beat blood pressure and cardiovascular parameters, and the ForeSight IQ system for tissue oxygen saturation over both lower legs. Monitoring sensors are placed after anesthesia induction, without altering standard surgical or anesthetic care. The monitoring data are recorded throughout the surgery but will not influence clinical decisions. Postoperative assessments of limb pain, sensation, and motor function will be done in the recovery unit. Participants will be monitored intraoperatively for tissue oxygen desaturation events, defined as a significant drop in tissue oxygen levels lasting over five minutes. Researchers will also assess correlations between these events and postoperative limb symptoms up to two hours after surgery. Additional data such as patient demographics and surgical details will be collected and securely stored. The study poses minimal risk and aims to generate preliminary data to improve early detection and prevention strategies for limb ischemia during such surgeries.
CONDITIONS
Brief Title
Feasibility and Clinical Utility of Paired Non-Invasive Hemodynamic and Tissue Oximetry Monitoring to Detect Limb Ischemia in Lithotomy-Positioned Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients
- Undergoing minimally invasive pelvic surgery such as hysterectomy, myomectomy, or endometriosis surgery
- Surgery performed in lithotomy position
- Surgery expected to last more than 2 hours as determined by the primary surgeon
You will not qualify if you...
- Pregnant patients
- Procedures expected to last less than 2 hours
- Open surgical approaches
- Minor procedures
- Known allergy or sensitivity to adhesives used for monitoring sensors
- Vulnerable populations such as incarcerated, elderly, or pregnant individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgery (greater than 2 hours)
Participants undergo continuous non-invasive hemodynamic and tissue oxygen saturation monitoring during their prolonged minimally invasive pelvic surgery performed in the lithotomy position. No changes to surgical or anesthetic care are made based on monitoring data.
1 intraoperative monitoring session
Duration - Up to 30 days post-surgery with immediate assessment up to 2 hours after surgery
Participants complete a brief assessment of lower-limb pain, sensation, and motor function in the post-anesthesia care unit. Medical records are reviewed for up to 30 days to identify any complications related to lower-extremity perfusion.
1 post-anesthesia care unit visit and electronic medical record review
Trial Site Locations
Total: 2 locations
1
Memorial Hermann Medical Center
Houston, Texas, United States, 77027
Not Yet Recruiting
2
Memorial Hermann Hospital
Houston, Texas, United States, 77401
Actively Recruiting
Research Team
R
Randa Jalloul, MD, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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