Hyperoxia
Conditions
Keywords
Hyperoxia, One-Lung Ventilation, Thoracic Surgery, Anesthesiology
Brief summary
The purpose of this study is to test the hypothesis that decreasing the inspired oxygen concentration during thoracic surgery requiring one lung ventilation will improve post-operative oxygenation.
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).
Interventions
DRUG60% oxygen
An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.
DRUG100% oxygen
An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults, 18 years of age and older, male or female. 2. American Society of Anesthesiology (ASA) physical status I, II, III or IV 3. Subjects who are scheduled for elective primary pulmonary lobectomy. 4. Subjects who have an arterial line placed as part of routine anesthetic management 5. Subjects who can understand and communicate in English.
Exclusion criteria
1. Subjects with a history of difficult intubation 2. Subjects with a high risk of aspiration during induction of anesthesia 3. Subjects with morbid obesity (BMI greater than or equal to 40) 4. Subjects with unable to provide consent 5. Subjects who are minors 6. Subjects who are not English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PaO2 to FiO2 ratio | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | Mortality will be determined by accessing the medical record. |
| Hypoxemia less than 90% | Intra-operative | This will be recorded from the intraoperative data acquired during surgery. |
| Blood level of receptor of advanced glycation end-products (RAGE) protein | 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. |
Countries
United States
Outcome results
None listed