Clinical Trial: The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy: A Randomized Controlled Trial
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 Summary:
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).
Sponsor: Yale University
Current Primary Outcome: PaO2 to FiO2 ratio [ Time Frame: Post-operative day 1 ]
Original Primary Outcome: PaO2 to FiO2 ratio [ Time Frame: Post-operative day 1 ]
Current Secondary Outcome:
- Mortality [ Time Frame: 30 days ]Mortality will be determined by accessing the medical record.
- Mortality [ Time Frame: 1 year ]Mortality will be determined by accessing the medical record.
- Hypoxemia less than 90% [ Time Frame: Intra-operative ]This will be recorded from the intraoperative data acquired during surgery.
- 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.
Original Secondary Outcome:
- Mortality [ Time Frame: 30 days ]
- Mortality [ Time Frame: 1 year ]
- Hypoxemia less than 90% [ Time Frame: Intra-operative ]
- Blood level of receptor of advanced glycation end-products (RAGE) protein [ Time Frame: Post-operative day 1 ]
Information By: Yale University
Dates:
Date Received: July 23, 2015
Date Started: December 2016
Date Completion: July 2018
Last Updated: August 23, 2016
Last Verified: August 2016