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NCT00715338 Clinical Trial

Effects of Oxygen on Lung Tissue During Anesthesia

Lung Injury, Acute Clinical Trial

Official title:
Effects of Oxygen on Lung Tissue During Anesthesia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00715338
Other study ID # 70808
Secondary ID
Status Terminated
Phase N/A
First received July 10, 2008
Last updated April 19, 2017
Start date June 2008
Est. completion date September 2008

Study information
Verified date April 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

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