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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnant patients

Procedures expected to last < 2 hours

Open surgical approaches

Minor procedures

Trial design

Treatments tested in this trial

  • Lower-Extremity Perfusion Monitoring

Treatment groups

30 Participants
are divided into 1 treatment group