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

NCT ID: NCT05538858

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-05-19

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.

Conditions

Mechanical Ventilation Complication; Vascular Injury; Endothelial Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mechanical Ventilation

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

Mechanical Ventilation

Intervention Type: PROCEDURE

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.

No interventions assigned to this group

Interventions

Mechanical Ventilation

Positive pressure mechanical ventilation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Asher Mendelson

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asher Mendelson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Health Sciences Center

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

HS25427

Identifier Type: -

Identifier Source: org_study_id