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.
