Feasibility of paired non-invasive blood flow and tissue oxygen monitoring to detect limb ischemia during lithotomy-position surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational pilot study enrolling about 30 adults undergoing minimally invasive pelvic surgeries in lithotomy position for at least 2 hours. The study uses two non-invasive devices to continuously monitor hemodynamics and tissue oxygenation in the lower limbs to see how often and how long tissue desaturation occurs and how those events relate to later limb pain, sensation, and motor function. It is non-interventional with minimal risk, aiming to generate preliminary data to guide future prevention and detection strategies for limb ischemia and well-leg syndrome. The primary outcome is desaturation frequency and duration; secondary outcomes explore associations with postoperative limb outcomes. Data will inform whether this monitoring approach can enhance early identification of limb ischemia during surgery.

Why it matters

Who can join: the full rules

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)

Where it's running

• Memorial Hermann Hospital
  Houston, Texas, United States Recruiting
• Memorial Hermann Medical Center
  Houston, Texas, United States Not yet recruiting

Study contacts

• Study coordinator: Randa Jalloul, MD, MS
• Email: randa.j.jalloul@uth.tmc.edu
• Phone: 7134867700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Home-use Erchonia EVRL laser for temporary relief of idiopathic peripheral neuropathy foot pain

  This study will test whether a home-use Erchonia EVRL laser can provide temporary relief of foot pain for adults with idiopathic peripheral neuropathy.

  Recruiting Erchonia Corporation · Miramar, Florida · NCT06912646

• Blood microRNA markers for chemotherapy-related peripheral nerve damage in lung and colorectal cancer

  This study will test whether levels of tiny blood molecules called microRNAs can predict how often and how badly patients with lung or colorectal cancer get nerve damage from certain chemotherapies.

  Recruiting University Hospital, Clermont-Ferrand · Clermont-Ferrand · NCT07427537

• Using neuromodulation to treat pain from chemotherapy-induced peripheral neuropathy

  This study is testing a new way to relieve pain from nerve damage caused by chemotherapy in patients with lower extremity CIPN.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT06121232

• Electrical stimulation to improve recovery after cubital tunnel surgery

  This study is testing a new electrical stimulation treatment to see if it helps people recover better after surgery for cubital tunnel syndrome.

  Recruiting at 2 sites Epineuron Technologies Inc. · Hamilton, Ontario and 1 other locations · NCT05980767

• Evaluating Ketotifen's protective role against chemotherapy-induced nerve damage

  This study is testing if Ketotifen can help prevent nerve damage caused by chemotherapy in people with stage III colorectal cancer.

  Recruiting Phase 3 Tanta University · Tanta, Other · NCT05624138

• Peripheral nerve block for painful diabetic neuropathy

  This study is testing if a nerve block can help adults with painful diabetic neuropathy feel less pain without stopping their regular medications.

  Recruiting University of Aarhus · Aarhus N, Jutland · NCT04699734

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.