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Completed

NCT Number: NCT05538858

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

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

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Key information

Conditions

Mechanical Ventilation Complication Cardiovascular Diseases Endothelial Dysfunction Vascular Diseases Vascular Injury Vascular System Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences Center

Winnipeg, Manitoba, R3A 1R9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mechanical ventilation

Procedure

Positive pressure mechanical ventilation

Primary outcomes

  1. Relative change of postoperative Granulocyte-macrophage colony-stimulating factor (GM-CSF) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  2. Relative change of postoperative Interferon gamma (IFNγ) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  3. Relative change of postoperative Interleukin-1β plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  4. Relative change of postoperative Interleukin-1RA plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  5. Relative change of postoperative Interleukin-2 plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  6. Relative change of postoperative Interleukin-4 plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  7. Relative change of postoperative Interleukin-5 plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  8. Relative change of postoperative Interleukin-6 plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  9. Relative change of postoperative Interleukin-8 plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  10. Relative change of postoperative Interleukin-10 plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  11. Relative change of postoperative Interleukin-12(p40) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  12. Relative change of postoperative Interleukin-12(p70) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  13. Relative change of postoperative Interleukin-13 plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  14. Relative change of postoperative Monocyte Chemoattractant Protein-1 (MCP-1) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  15. Relative change of postoperative Tumor Necrosis Factor Alpha (TNFα) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  16. Relative change of postoperative Soluble platelet endothelial cell adhesion molecule-1 (sPECAM-1) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  17. Relative change of postoperative Vascular Cell Adhesion Molecule 1 (VCAM-1) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  18. Relative change of postoperative Vascular Endothelial Growth Factor (VEGF) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  19. Relative change of postoperative Angiopoietin 2 (Ang-2) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  20. Relative change of postoperative Tyrosine-protein kinase receptor Tie-2 (sTIE-2) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  21. Relative change of postoperative Soluble platelet selectin (sP-selectin) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  22. Relative change of postoperative Soluble endothelial selectin (sE-selectin) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  23. Relative change of postoperative Soluble intercellular adhesion molecule-1 (sICAM-1) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  24. Relative change of postoperative thrombomodulin plasma concentration relative to preoperative plasma concentration

    Time frame: 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

  25. Relative change of postoperative von Willebrand factor (vWF) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

Secondary outcomes

  1. Relative change of postoperative Semaphorin 3E (sema3E) plasma concentration relative to preoperative plasma concentration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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