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NCT05538858 Clinical Trial

Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study

Endothelial Dysfunction Clinical Trial

Official title:
Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05538858
Other study ID # HS25427
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 15, 2022
Est. completion date May 19, 2023

Study information
Verified date May 2023
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Investigation of the effect of mechanical ventilation on biomarkers of microvascular damage

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date May 19, 2023
Est. primary completion date May 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Shock

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Mechanical Ventilation
Positive pressure mechanical ventilation

Locations
Country Name City State
Canada Health Sciences Center Winnipeg Manitoba

Sponsors (1)
Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relative change of postoperative Granulocyte-macrophage colony-stimulating factor (GM-CSF) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interferon gamma (IFN?) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-1ß plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-1RA plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-2 plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-4 plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-5 plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-6 plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-8 plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-10 plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-12(p40) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-12(p70) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Interleukin-13 plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Monocyte Chemoattractant Protein-1 (MCP-1) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Tumor Necrosis Factor Alpha (TNFa) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Soluble platelet endothelial cell adhesion molecule-1 (sPECAM-1) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Vascular Cell Adhesion Molecule 1 (VCAM-1) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Vascular Endothelial Growth Factor (VEGF) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Angiopoietin 2 (Ang-2) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Tyrosine-protein kinase receptor Tie-2 (sTIE-2) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Soluble platelet selectin (sP-selectin) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Soluble endothelial selectin (sE-selectin) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative Soluble intercellular adhesion molecule-1 (sICAM-1) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative thrombomodulin plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Primary Relative change of postoperative von Willebrand factor (vWF) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
Secondary Relative change of postoperative Semaphorin 3E (sema3E) plasma concentration relative to preoperative plasma concentration Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure Immediately prior to surgical procedure to immediately after surgical procedure
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