Lung Injury, AcuteNCT00715338
Effects of Oxygen on Lung Tissue During Anesthesia
An observational study of Lung Injury, Acute, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Injury, Acute
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for a routine surgical procedure
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
Read the 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.
- Conditions
- Lung Injury, Acute
- Keywords
- Exhaled Breath Condensate, elective surgery, mechanical ventilation, Isofurans, thrombomodulin, requiring, mechanical, ventilation
- Medical subject headings
- Acute Lung Injury, Respiratory Aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Injury, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Allan Barwis, Vanderbilt University
- Investigators
- John A Barwise, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715338
- Sponsor's protocol ID
- 70808
- Status last verified
- Apr 2017
- First submitted
- 10 Jul 2008
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxygen on Lung Tissue During Anesthesia
- ClinicalTrials.gov ID
- NCT00715338
- Acronym / sponsor ID
- 70808
- Conditions
- Lung Injury, Acute
- Keywords
- Exhaled Breath Condensate, elective surgery, mechanical ventilation, Isofurans, thrombomodulin, requiring, mechanical, ventilation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jun 2008 (actual)
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for a routine surgical procedure
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Vanderbilt University Medical Center Department of AnesthesiologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Barwise, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Injury, Acute, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.