The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy

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).

Official Title
-----------------
The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy: A Randomized Controlled Trial

Conditions
-----------------
Hyperoxia

Intervention / Treatment
-----------------
* Drug: 60% oxygen
* Drug: 100% oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 100% FiO2<br>100% oxygen administered during pulmonary lobectomy surgery. | Drug: 100% oxygen<br>* An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.<br>* Other names: FiO2 100%;|
| Experimental: 60% FiO2<br>60% oxygen administered during pulmonary lobectomy surgery. | Drug: 60% oxygen<br>* An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.<br>* Other names: FiO2 60%;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2 to FiO2 ratio | 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 | Mortality will be determined by accessing the medical record. | 30 days | 
| Mortality | Mortality will be determined by accessing the medical record. | 1 year | 
| Hypoxemia less than 90% | This will be recorded from the intraoperative data acquired during surgery. | Intra-operative | 
| Blood level of receptor of advanced glycation end-products (RAGE) protein | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperoxia, One-Lung Ventilation, Thoracic Surgery, Anesthesiology