Monitoring Blood Flow to Detect Limb Ischemia during Surgery
Feasibility and Clinical Utility of Paired Non-Invasive Hemodynamic and Tissue Oximetry Monitoring to Detect Limb Ischemia in Lithotomy-Positioned Surgeries
Recruiting
Observational Study
Neuropathy;PeripheralLimb Ischemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Female
Study type
Observational
Participants needed
30 (estimated)
Sponsor
The University of Texas Health Science Center, Houston · Other
Who this trial is looking for
This trial is looking for adults who are having certain types of pelvic surgery that may last longer than two hours. Participants will have their blood flow and oxygen levels in their legs monitored during the surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am an adult
I am having minimally invasive pelvic surgery
My surgery will be done in the lithotomy position
My surgery is expected to last longer than 2 hours
You may not be able to join if
I am pregnant
My surgery is expected to last less than 2 hours
I am having an open surgery
I am having a minor procedure
I am allergic to the adhesives used for monitoring sensors
I am in a vulnerable population such as being incarcerated or elderly
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 desatur…
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
Trial Locations
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Eligibility Criteria
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. Pregna…
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)
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