跳至主要内容
临床试验/NCT07387653
NCT07387653招募中不适用

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

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
StO₂ desaturation episodes

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Pregnant patients
  • Procedures expected to last < 2 hours
  • Open surgical approaches
  • Minor procedures
  • Known allergy or sensitivity to adhesives used for monitoring sensors
  • Vulnerable populations (incarcerated, elderly or pregnant)

研究组 & 干预措施

Prolonged Lithotomy Surgery Cohort

Prolonged Lithotomy Surgery Cohort

干预措施: Lower-Extremity Perfusion Monitoring (Other)

结局指标

主要结局

StO₂ desaturation episodes

时间窗: Duration of the surgery

Intraoperative lower-limb tissue oxygenation events, defined as the number and duration of StO₂ desaturation episodes, including a drop \>15% from baseline or an absolute StO₂ \<50% lasting more than 5 minutes, recorded continuously during surgery

次要结局

  • Postoperative lower-limb symptoms- Pain(up to 2 hours)
  • Postoperative lower-limb symptoms-Motor(up to 2 hours post surgery)
  • Post-operative Limb symptom- sensation(up to 2 hours after surgery)

研究者

发起方
The University of Texas Health Science Center, Houston
申办方类型
Other
责任方
Principal Investigator
主要研究者

Randa Jalloul

Associate Professor

The University of Texas Health Science Center, Houston

研究点 (2)

Loading locations...

相似试验

进行中(未招募)
不适用
An eight-week, multicenter, randomized, double-blind, placebo-controlled dose-finding study, with escitalopram (10mg daily) as active control, to evaluate the efficacy, safety and tolerability of three fixed doses of SSR411298 (10, 50, or 200mg daily) in elderly patients with Major Depressive DisorderMedDRA version: 11.0Level: LLTClassification code 10025453Term: <Manually entered code. Term in E.1.1>Major Depressive Disorder
EUCTR2008-001718-26-SKSanofi-Aventis Recherche & Développement500
进行中(未招募)
不适用
A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2)Iron deficiency anaemia in quiescent Crohn's DiseaseMedDRA version: 14.1Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1Level: LLTClassification code 10002062Term: Anaemia iron deficiencySystem Organ Class: 10005329 - Blood and lymphatic system disorders
EUCTR2010-023589-39-ATIron Therapeutics (Switzerland) AG60
进行中(未招募)
1 期
A study of a new iron medication for people with Crohn's Disease that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 2)Iron deficiency anaemia in quiescent Crohn's DiseaseMedDRA version: 14.1 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 14.1 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 10005329 - Blood and lymphatic system disorders
EUCTR2010-023589-39-GBIron Therapeutics (Switzerland) AG128
进行中(未招募)
1 期
clinical trial to assess efficacy and safety of masitinib in the treatment of Chronic Obstructive Pulmonary DiseaseSevere Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
EUCTR2012-005586-13-SKAB Science45
进行中(未招募)
1 期
Evaluation of masitinib in acute ischemic strokepatients suffering from Acute Ischemic StrokeMedDRA version: 18.1Level: LLTClassification code 10023027Term: Ischaemic stroke NOSSystem Organ Class: 100000004852
EUCTR2010-020603-79-SKAB Science48