Effects of Oxygen on Lung Tissue During Anesthesia

NCT ID: NCT00715338

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Injury, Acute

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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John Allan Barwis

Asssistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John A Barwise, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.vandydreamteam.com

Vanderbilt University Medical Center Department of Anesthesiology

Other Identifiers

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70808

Identifier Type: -

Identifier Source: org_study_id

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