Expired Study
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New Haven, Connecticut 06510


Purpose:

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.


Study 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).


Criteria:

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


Study is Available At:


Original ID:

1507016157


NCT ID:

NCT02509182


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Yale University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

Study never officially began


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Wanda Popescu, MD
Principal Investigator
Yale University

Study Dates

Start Date:December 2016
Completion Date:July 2018
Completion Type:Anticipated
Primary Completion Date:July 2017
Primary Completion Type:Anticipated
Verification Date:January 2018
Last Changed Date:January 10, 2018
First Received Date:July 23, 2015

Study Outcomes

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

Study Interventions

Intervention Type:Drug
Name:60% oxygen
Description:An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.
Arm Name:60% FiO2
Other Name:FiO2 60%
Intervention Type:Drug
Name:100% oxygen
Description:An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.
Arm Name:100% FiO2
Other Name:FiO2 100%

Study Arms

Study Arm Type:Experimental
Arm Name:60% FiO2
Description:60% oxygen administered during pulmonary lobectomy surgery.
Study Arm Type:Active Comparator
Arm Name:100% FiO2
Description:100% oxygen administered during pulmonary lobectomy surgery.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Yale University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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