Effects of Oxygen on Lung Tissue During Anesthesia

Sponsor

Vanderbilt University (Other)

Overall Status

Terminated

CT.gov ID

NCT00715338

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Injury, Acute

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Effects of Oxygen on Lung Tissue During Anesthesia

Actual Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.