- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509182
The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy
The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy: A Randomized Controlled Trial
Study Overview
Detailed Description
One lung ventilation is frequently required during thoracic surgery and results in decreased lung function post-operatively. Supra-physiologic oxygen levels during surgery may contribute to this decrease in lung function by worsening lung injury intra-operatively.
This study will include patients undergoing surgery to remove a lung lobe requiring one lung ventilation.
The patients will be divided into two groups with the experimental group receiving a 60% oxygen in air mixture and the control group receiving 100% oxygen.
The two groups will be compared by using a measure of lung function (the ratio of the partial pressure of oxygen in arterial blood to the inspired oxygen concentration) and blood levels of a protein correlated with lung injury (receptor of advanced glycation end products RAGE).
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06510
- Yale New Haven Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults, 18 years of age and older, male or female.
- American Society of Anesthesiology (ASA) physical status I, II, III or IV
- Subjects who are scheduled for elective primary pulmonary lobectomy.
- Subjects who have an arterial line placed as part of routine anesthetic management
- Subjects who can understand and communicate in English.
Exclusion Criteria:
- Subjects with a history of difficult intubation
- Subjects with a high risk of aspiration during induction of anesthesia
- Subjects with morbid obesity (BMI greater than or equal to 40)
- Subjects with unable to provide consent
- Subjects who are minors
- Subjects who are not English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 100% FiO2
100% oxygen administered during pulmonary lobectomy surgery.
|
An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.
Other Names:
|
Experimental: 60% FiO2
60% oxygen administered during pulmonary lobectomy surgery.
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An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PaO2 to FiO2 ratio
Time Frame: Post-operative day 1
|
The ratio of the partial pressure of oxygen in arterial blood (PaO2) to the inspired oxygen concentration (FiO2).
An arterial blood sample will be drawn from an arterial line on post-operative day 1 and the FiO2 at the time of blood draw will be documented to calculate the ratio.
|
Post-operative day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 30 days
|
Mortality will be determined by accessing the medical record.
|
30 days
|
Mortality
Time Frame: 1 year
|
Mortality will be determined by accessing the medical record.
|
1 year
|
Hypoxemia less than 90%
Time Frame: Intra-operative
|
This will be recorded from the intraoperative data acquired during surgery.
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Intra-operative
|
Blood level of receptor of advanced glycation end-products (RAGE) protein
Time Frame: Post-operative day 1
|
The receptor of advanced glycation end-products (RAGE) protein levels correlates with alveolar epithelial lung cell injury and will be measured in a blood sample collected on post-operative day 1.
|
Post-operative day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wanda Popescu, MD, Yale University
- Principal Investigator: Nathan Clendenen, MD,MS, Yale University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1507016157
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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