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临床试验/NCT02688946
NCT02688946已完成不适用

Imaging Microcirculation And Gross Hemodynamic Assessment of the Bowel During Elective Colorectal Surgery

St. Antonius Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Microvascular flow index (MFI)

研究概览

简要总结

Rationale: The interaction between macro and microcirculation remains uncertain. Microvascular alterations can occur when systemic hemodynamic parameters are within an acceptable range. Perfusion changes and microvascular alterations may play an important role in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery. Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to anastomosis creation. However, local oxygen delivery may still be compromised as little is known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging modality incorporated in a hand-held device, which illuminates an area of interest and provides high contrast dynamic images of the microvasculature. DF-imaging enables to visualize the bowel's microcirculation.

Objective: To describe the human gastrointestinal microcirculation during gastrointestinal surgery under general anesthesia and to observe whether there is a correlation between bowel microcirculation and systemic hemodynamic parameters.

Study design: A prospective, single center, observational, clinical, pilot study.

Study population: 70 patients undergoing elective, gastrointestinal surgery during which the gastrointestinal tract is accessible for DF-imaging.

Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both the serosal and mucosal side of the bowel during gastrointestinal surgery under general anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular Flow Index (MFI).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extend of burden and risk associated with participation is negligible. Using DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time as is described in the study procedure. Previous studies did not show any safety concerns. Measuring will be performed under sterile conditions and the occurrence of tissue damage is highly unlikely. Patients are under general anesthesia and will thus not experience any inconvenience.

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

  • All patients aged >18 scheduled for elective, gastrointestinal surgery (as described above) with signed informed consent.

排除标准

  • • Age <18 years;
  • Atrial fibrillation (because of possible interference with FloTrac™/Vigileo™ cardiac output monitor);
  • Left ventricular ejection fraction ≤30%;
  • Serious pulmonary disease (resting pO2 <90% at room air);
  • Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula);
  • Liver failure;
  • No signed informed consent.

结局指标

主要结局

Microvascular flow index (MFI)

时间窗: Intra-operative

During surgery

次要结局

  • Perfused vessel density (PVD)(Intra-operative)
  • Heterogeneity index (HI)(During surgery)
  • Total vessel density (TVD)(Intra-operative)
  • Proportion of perfused vessels (PPV)(Intra-operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. P. Noordzij

Coordinating investigator

St. Antonius Hospital

研究点 (1)

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