This trial is active, not recruiting.

Condition lung injury, acute
Sponsor Vanderbilt University
Start date June 2008
End date June 2009
Trial size 40 participants
Trial identifier NCT00715338, 70808


Collect exhaled breath condensates from patients scheduled for a routine surgical procedure before, during, and after surgery for measurements of IsoFs

Draw blood from patients scheduled for a routine surgical procedure before, during, and after surgery for measurements of serum thrombomodulin.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - American Society of Anesthesiologists (ASA) Class I-III. - Patient is undergoing elective surgery requiring mechanical ventilation - Patient is an adult, 18 - 80 years old. - Subject has voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB). Exclusion Criteria: - Surgical procedures boarded for less than 2 hours - Current Smoker - All Cardiac, Thoracic and/or Vascular surgeries involving the chest - Patient unable to cooperate. - Chronic airway diseases - Asthma - Medical contraindication to anesthetic technique (allergy, cardiac condition, neurologic condition, localized infection, bleeding disorder). - Subjects who are pregnant.

Additional Information

Official title Effects of Oxygen on Lung Tissue During Anesthesia
Principal investigator John A Barwise, M.D.
Description High concentrations of oxygen are routinely administered to patients undergoing routine surgical procedures even though it is highly likely, at least in patients with normal lung function, that this is unnecessary and in fact may be doing unnecessary harm. Therefore, we plan to assess whether there is any evidence of lung injury during surgery resulted from administration of high concentrations of oxygen by measuring Isofurans (IsoFs) in exhaled breath condensate. In our studies in mice that were exposed to high concentrations of oxygen we also found that circulating levels of thrombomodulin were increased. Thrombomodulin is present in endothelial cells and upon injury they release thrombomodulin into the circulation. Endothelial cell injury is known to occur in hyperoxic-induced lung injury. Therefore, in addition to measuring IsoFs in exhaled breath condensate we will also measure plasma concentrations of thrombomodulin as an indicator of endothelial injury.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by Vanderbilt University.