NCT05538858

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2023

Completed
Last Updated

August 24, 2025

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

September 11, 2022

Last Update Submit

August 19, 2025

Conditions

Mechanical Ventilation ComplicationVascular InjuryEndothelial Dysfunction

Outcome Measures

Primary Outcomes (25)

  • 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

  • Relative change of postoperative Interferon gamma (IFNγ) 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

  • Relative change of postoperative Interleukin-1β 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Relative change of postoperative Tumor Necrosis Factor Alpha (TNFα) 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

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

    Immediately prior to surgical procedure to immediately after surgical procedure

Study Arms (2)

Mechanical Ventilation

Cohort will undergo standard of care treatment utilizing a general anesthetic with mechanical ventilation for a surgical procedure.

Procedure: Mechanical Ventilation

Control

Cohort will undergo standard of care treatment utilizing a regional or neuraxial anesthetic without mechanical ventilation for a surgical procedure.

Interventions

Mechanical VentilationPROCEDURE

Positive pressure mechanical ventilation

Mechanical Ventilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing elective orthopedic, endourologic, or plastic surgery procedure amenable to both general anesthetic or regional/neuraxial anesthesia.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Center

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Vascular System Injuries

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Asher Mendelson, Ph.D.

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 11, 2022

First Posted

September 14, 2022

Study Start

December 15, 2022

Primary Completion

May 19, 2023

Study Completion

May 19, 2023

Last Updated

August 24, 2025

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)