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

Sponsor

University of Manitoba (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05538858

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mechanical Ventilation Complication Vascular Injury Endothelial Dysfunction	Procedure: Mechanical Ventilation

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

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Mechanical Ventilation Cohort will undergo standard of care treatment utilizing a general anesthetic with mechanical ventilation for a surgical procedure.	Procedure: Mechanical Ventilation Positive pressure mechanical ventilation
Control Cohort will undergo standard of care treatment utilizing a regional or neuraxial anesthetic without mechanical ventilation for a surgical procedure.

Arm

Intervention/Treatment

Mechanical Ventilation

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

Procedure: Mechanical Ventilation

Positive pressure mechanical ventilation

Control

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

Outcome Measures

Primary Outcome Measures

Relative change of postoperative serum vascular endothelial biomarker levels relative to preoperative values [Relative comparison of immediate preoperative levels to immediate postoperative levels.]
Biomarkers include: VCAM-1, VCAM-2, VEGF, Ang-1, Ang-2, sTIE-1, sTIE-2, Sema3E, sP-selectin, sE-selectin, sICAM-1, sVE-cadherin, vWF, IL-1, IL-6, IL-10, TNF-a.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients undergoing orthopedic, endourologic, or plastic surgery procedure which is both: (1) amenable to both general anesthetic or regional/neuraxial anesthesia AND (2) elective OR E2/3/4 emergent.

Exclusion Criteria:

E1 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 before the procedure; diagnosed infection; shock.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Manitoba

Investigators

Principal Investigator: Asher Mendelson, Ph.D., University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asher Mendelson, Assistant Professor, University of Manitoba

ClinicalTrials.gov Identifier:

NCT05538858

Other Study ID Numbers:

HS25427

First Posted:

Sep 14, 2022

Last Update Posted:

Sep 14, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vascular System Injuries

Wounds and Injuries

Study Results

No Results Posted as of Sep 14, 2022