Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Relative change of postoperative Interleukin-2 plasma concentration relative to preoperative plasma concentration
研究概览
简要总结
Investigation of the effect of mechanical ventilation on biomarkers of microvascular damage
详细描述
The objective of this study is to determine the effect of mechanical ventilation (MV) on endothelial biomarkers associated with ventilator-induced vascular injury (VIVI), and determine the correlation of these biomarkers with non-invasive microvascular perfusion monitoring data and semaphorin 3E levels.
Blood samples will be collected immediately pre-operatively and post-operatively.
Biomarkers will be expressed as an absolute value and as a relative percentage change from baseline to account for inter-individual variability. Hemodynamic and surgical variables will be extracted from the OR data: blood pressure, oxygen saturation, blood loss, fluid administration, length of surgery, and MV parameters such as tidal volume, inspired oxygen, respiratory rate, and positive end-expiratory pressure.
During surgery, patients will be monitored using a non-invasive near-infrared spectroscopy technique to quantify skeletal muscle microvascular perfusion. These devices will be applied immediately prior to induction of anesthetic and data collected until immediately prior to transfer to the post-anesthesia care unit.
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
- 是
入选标准
- •Age 18 years or greater
- •Patients undergoing elective orthopedic, endourologic, or plastic surgery procedure which is amenable to both general anesthetic or regional/neuraxial anesthesia
排除标准
- •Emergency surgery
- •Polytrauma
- •Tourniquet use
- •Controlled hypotension
- •Mechanical ventilation less than 60 minutes in duration
- •American Society of Anesthesiologists class 4 or greater
- •Status postpneumonectomy
- •Pulmonary hypertension
- •Oxygen therapy during last month
- •Severe obesity (body mass index ≥40 kg/m2)
- •Immunosuppression within 3 months
- •Diagnosed infection
结局指标
主要结局
Relative change of postoperative Interleukin-2 plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-5 plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-12(p40) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-13 plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Monocyte Chemoattractant Protein-1 (MCP-1) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Tumor Necrosis Factor Alpha (TNFα) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-8 plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-10 plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Vascular Cell Adhesion Molecule 1 (VCAM-1) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Tyrosine-protein kinase receptor Tie-2 (sTIE-2) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interferon gamma (IFNγ) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-6 plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Vascular Endothelial Growth Factor (VEGF) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Soluble platelet selectin (sP-selectin) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Granulocyte-macrophage colony-stimulating factor (GM-CSF) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-4 plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative von Willebrand factor (vWF) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-1β plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-1RA plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-12(p70) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Soluble platelet endothelial cell adhesion molecule-1 (sPECAM-1) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Soluble endothelial selectin (sE-selectin) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Soluble intercellular adhesion molecule-1 (sICAM-1) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Angiopoietin 2 (Ang-2) plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative thrombomodulin plasma concentration relative to preoperative plasma concentration
时间窗: Immediately prior to surgical procedure to immediately after surgical procedure
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
次要结局
- Relative change of postoperative Semaphorin 3E (sema3E) plasma concentration relative to preoperative plasma concentration(Immediately prior to surgical procedure to immediately after surgical procedure)
研究者
Asher Mendelson
Assistant Professor
University of Manitoba