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

U

University of Manitoba

Status

Completed

Conditions

Endothelial Dysfunction
Mechanical Ventilation Complication
Vascular Injury

Treatments

Procedure: Mechanical Ventilation

Study type

Observational

Funder types

Other

Identifiers

NCT05538858
HS25427

Details and patient eligibility

About

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

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

19 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Asher Mendelson, Ph.D.

Data sourced from clinicaltrials.gov

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