Clinical trial NCT05538858: Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study
Official title: Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Vascular Injury
Endothelial Dysfunction
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective orthopedic, endourologic, or plastic surgery procedure amenable to both general anesthetic or regional/neuraxial anesthesia.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative change of postoperative Granulocyte-macrophage colony-stimulating factor (GM-CSF) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interferon gamma (IFNγ) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-1β plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-1RA plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-2 plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-4 plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-5 plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-6 plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-8 plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-10 plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-12(p40) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-12(p70) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Interleukin-13 plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Monocyte Chemoattractant Protein-1 (MCP-1) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Tumor Necrosis Factor Alpha (TNFα) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Soluble platelet endothelial cell adhesion molecule-1 (sPECAM-1) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Vascular Cell Adhesion Molecule 1 (VCAM-1) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Vascular Endothelial Growth Factor (VEGF) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Angiopoietin 2 (Ang-2) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Tyrosine-protein kinase receptor Tie-2 (sTIE-2) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Soluble platelet selectin (sP-selectin) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Soluble endothelial selectin (sE-selectin) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative Soluble intercellular adhesion molecule-1 (sICAM-1) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative thrombomodulin plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
measure: Relative change of postoperative von Willebrand factor (vWF) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
Secondary outcomes:
measure: Relative change of postoperative Semaphorin 3E (sema3E) plasma concentration relative to preoperative plasma concentration
timeFrame: Immediately prior to surgical procedure to immediately after surgical procedure
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Center
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Asher Mendelson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: