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 ]

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.


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