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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05538858
Enrollment
19
Registered
2022-09-14
Start date
2022-12-15
Completion date
2023-05-19
Last updated
2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Mechanical Ventilation Complication, Vascular Injury

Brief summary

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

Detailed 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.

Interventions

PROCEDUREMechanical Ventilation

Positive pressure mechanical ventilation

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Relative change of postoperative von Willebrand factor (vWF) plasma concentration relative to preoperative plasma concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Relative change of postoperative Interleukin-2 plasma concentration relative to preoperative plasma concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage 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 concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure

Secondary

MeasureTime frameDescription
Relative change of postoperative Semaphorin 3E (sema3E) plasma concentration relative to preoperative plasma concentrationImmediately prior to surgical procedure to immediately after surgical procedurePercentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026