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

Hyperoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02509182
• Other study ID #: 1507016157
• Status: Withdrawn
• Phase: Phase 4
• First received: July 23, 2015
• Last updated: January 10, 2018
• Start date: December 2016
• Est. completion date: July 2018

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperoxia

Intervention

Drug:
• 60% oxygen
An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.
• 100% oxygen
An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Mortality will be determined by accessing the medical record.	30 days
Secondary	Mortality	Mortality will be determined by accessing the medical record.	1 year
Secondary	Hypoxemia less than 90%	This will be recorded from the intraoperative data acquired during surgery.	Intra-operative
Secondary	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