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临床试验/NCT07179549
NCT07179549尚未招募不适用

Evaluation of the Incidence of Myocardial Damage Following Upper and Lower Gastrointestinal Endoscopy in High-risk Patients: MINS-Endoscopy Study

European Society of Anaesthesiology0 个研究点目标入组 120 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Ultra-sensitive Troponin I plasma level

研究概览

简要总结

Hypoperfusion occurs following anaesthesia induction as a result of:

  1. a reduction in venous return and cardiac output subsequent to the dilatation of the venous reservoir, and
  2. a reduction in mean arterial pressure (MAP) secondary to arteriolar vasodilatation (reduction in arterial resistance) and decreased cardiac output. Many studies in the literature have focused on intraoperative hypotension and have reported an association between intensity x duration of hypotension and the occurrence of postoperative adverse events. Smaller interventional studies have suggested that improving stroke volume (SV, and therefore cardiac output) using fluid titration could reduce postoperative complications. Among postoperative adverse events consecutive to hypoperfusion, the occurrence of myocardial injury after noncardiac surgery (MINS) is well documented and is correlated to postoperative mortality at day 30.

Upper and lower gastro-intestinal (GI) endoscopies are frequently performed under sedation (i.e.: general anaesthesia without orotracheal intubation) as daycare procedures. More than 10% of all anaesthesia worldwide is administered for GI endoscopic procedures. A substantial proportion of patients undergoing these procedures have significant comorbidities, classifying them as ASA 3 or ASA 4. However, despite the higher risk associated to their comorbidities, these patients are most often monitored intraoperatively as if they were ASA 1 or ASA 2, i.e.: using intermittent oscillometric blood pressure measurements every 5 minutes, an electrocardioscope and peripheral oxygen saturation measurement. They are also usually considered eligible for daycare procedures. However, hypoperfusion occurs during upper and lower GI endoscopies as a result of anaesthesia combined with abdominal insufflation (stomach followed by colon) and always starts with a decrease in SV, followed by a decrease in MAP.

The exact incidence of MINS following endoscopic procedures in high-risk patients has not been investigated to our knowledge and is not known precisely. The first part of this pragmatic study would consist in collecting pre-op and post-op (4 hours post procedure) plasma troponin level in ASA 3 or ASA 4 patients scheduled for upper and lower GI endoscopy at the time of routine blood collection. The patient will also be monitored using a Clearsight® continuous hemodynamic monitoring device.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Outpatients scheduled for upper and lower GI endoscopy
  • ASA class 3 or 4: patients considered by anesthesiologists at "high risk" of postoperative complications, based on their comorbidities

排除标准

  • Symptomatic coronary artery disease at the time of inclusion
  • Pulmonary embolism less than two weeks before inclusion
  • Septic shock less than two weeks before inclusion
  • Patients with renal failure, with glomerular filtration rate<40 ml/min
  • Patient not covered by social security
  • Patient is pregnant
  • Protected Patients

结局指标

主要结局

Ultra-sensitive Troponin I plasma level

时间窗: 4 hours

Ultra-sensitive Troponin I plasma level variation following upper and lower GI endoscopy. Troponin I will be measured immediately prior to anaesthesia induction (IV line placement) and before patient discharge of the hospital, i.e.: 4 (±1) hours after the procedure.

Ultra-sensitive Troponin I plasma level variation following upper and lower GI endoscopy.

时间窗: 4 hours

Ultra-sensitive Troponin I plasma level variation following upper and lower GI endoscopy. Troponin I will be measured immediately prior to anaesthesia induction (IV line placement) and before patient discharge from the hospital, i.e.: 4 (±1) hours after the procedure

次要结局

未报告次要终点

研究者

发起方
European Society of Anaesthesiology
申办方类型
Other
责任方
Sponsor

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