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Effects of Oxygen on Lung Tissue During Anesthesia

This study has been terminated.
(poor enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00715338
First Posted: July 15, 2008
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Allan Barwis, Vanderbilt University
  Purpose

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
Lung Injury, Acute

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Oxygen on Lung Tissue During Anesthesia

Resource links provided by NLM:


Further study details as provided by John Allan Barwis, Vanderbilt University:

Biospecimen Retention:   None Retained
serum

Enrollment: 10
Actual Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for a routine surgical procedure
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00715338


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: John A Barwise, M.D. Vanderbilt University Medical Center
  More Information

Additional Information:
Responsible Party: John Allan Barwis, Asssistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00715338     History of Changes
Other Study ID Numbers: 70808
First Submitted: July 10, 2008
First Posted: July 15, 2008
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by John Allan Barwis, Vanderbilt University:
Exhaled Breath Condensate
elective surgery
mechanical ventilation
Isofurans
thrombomodulin
requiring
mechanical
ventilation

Additional relevant MeSH terms:
Lung Injury
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries


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