The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Yale University
- Locations
- 1
- Primary Endpoint
- PaO2 to FiO2 ratio
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
100% FiO2
100% oxygen administered during pulmonary lobectomy surgery.
Intervention: 100% oxygen (Drug)
60% FiO2
60% oxygen administered during pulmonary lobectomy surgery.
Intervention: 60% oxygen (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Blood level of receptor of advanced glycation end-products (RAGE) protein(Post-operative day 1)
- Mortality(1 year)
- Hypoxemia less than 90%(Intra-operative)