Mechanical Ventilation ComplicationNCT05538858
Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study
An observational study of Mechanical Ventilation Complication and Vascular Injury, run by University of Manitoba at 1 site in Canada.
Trial summary
Investigation of the effect of mechanical ventilation on biomarkers of microvascular damage Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mechanical Ventilation Complication, Vascular Injury, Endothelial Dysfunction
- What is being tested?
- Mechanical Ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 15 Dec 2022to 19 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing elective orthopedic, endourologic, or plastic surgery procedure amenable to both general anesthetic or regional/neuraxial anesthesia.
Who may be able to join
- 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
Who cannot join
- Emergency surgery
- Polytrauma
- Tourniquet use
- Controlled hypotension
- Mechanical ventilation less than 60 minutes in duration
- American Society of Anesthesiologists class 4 or greater
Show all 13Show fewer
- Status postpneumonectomy
- Pulmonary hypertension
- Oxygen therapy during last month
- Severe obesity (body mass index ≥40 kg/m2)
- Immunosuppression within 3 months
- Diagnosed infection
- Shock
Trial locations and contacts
1 site in 1 country.
About this study
Investigation of the effect of mechanical ventilation on biomarkers of microvascular damage
Read the 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.
- Being tested
- Mechanical Ventilation
- Medical subject headings
- Vascular System Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical VentilationProcedure or surgery
Positive pressure mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Ventilation | Cohort will undergo standard of care treatment utilizing a general anesthetic with mechanical ventilation for a surgical procedure. Receives: Procedure: Mechanical Ventilation | |
| Control | Cohort will undergo standard of care treatment utilizing a regional or neuraxial anesthetic without mechanical ventilation for a surgical procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Percentage change in concentration from immediately prior to surgical procedure to immediately after surgical procedure
Measured: Immediately prior to surgical procedure to immediately after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start15 Dec 2022
- Primary completion19 May 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asher Mendelson, University of Manitoba
- Investigators
- Asher Mendelson, Ph.D., Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538858
- Sponsor's protocol ID
- HS25427
- Status last verified
- May 2023
- First submitted
- 11 Sep 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Injury in Mechanical Ventilation: a Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT05538858
- Acronym / sponsor ID
- HS25427
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Ventilation | – | Procedure: Mechanical VentilationCohort will undergo standard of care treatment utilizing a general anesthetic with mechanical ventilation for a surgical procedure. |
| Control | – | –Cohort will undergo standard of care treatment utilizing a regional or neuraxial anesthetic without mechanical ventilation for a surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective orthopedic, endourologic, or plastic surgery procedure amenable to both general anesthetic or regional/neuraxial anesthesia.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- Emergency surgery
- Polytrauma
- Tourniquet use
- Controlled hypotension
- Mechanical ventilation less than 60 minutes in duration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical VentilationPositive pressure mechanical ventilation | Procedure or surgery | Mechanical Ventilation |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asher Mendelson, Ph.D. principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication and Vascular Injury, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.