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

Primary Purpose

Hyperoxia

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

60% oxygen

100% oxygen

About this trial

This is an interventional prevention trial for Hyperoxia focused on measuring Hyperoxia, One-Lung Ventilation, Thoracic Surgery, Anesthesiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale New Haven Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

100% FiO2

60% FiO2

Arm Description

100% oxygen administered during pulmonary lobectomy surgery.

60% oxygen administered during pulmonary lobectomy surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality

Mortality will be determined by accessing the medical record.

Mortality

Mortality will be determined by accessing the medical record.

Hypoxemia less than 90%

This will be recorded from the intraoperative data acquired during surgery.

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.

Full Information

NCT ID

NCT02509182

First Posted

July 23, 2015

Last Updated

January 10, 2018

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT02509182

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Study never officially began

Study Start Date

December 2016 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperoxia

Keywords

Hyperoxia, One-Lung Ventilation, Thoracic Surgery, Anesthesiology

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100% FiO2

Arm Type

Active Comparator

Arm Description

100% oxygen administered during pulmonary lobectomy surgery.

Arm Title

60% FiO2

Arm Type

Experimental

Arm Description

60% oxygen administered during pulmonary lobectomy surgery.

Intervention Type

Drug

Intervention Name(s)

60% oxygen

Other Intervention Name(s)

FiO2 60%

Intervention Description

An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.

Intervention Type

Drug

Intervention Name(s)

100% oxygen

Other Intervention Name(s)

FiO2 100%

Intervention Description

An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.

Primary Outcome Measure Information:

Title

PaO2 to FiO2 ratio

Description

Time Frame

Post-operative day 1

Secondary Outcome Measure Information:

Title

Mortality

Description

Mortality will be determined by accessing the medical record.

Time Frame

30 days

Title

Mortality

Description

Mortality will be determined by accessing the medical record.

Time Frame

1 year

Title

Hypoxemia less than 90%

Description

This will be recorded from the intraoperative data acquired during surgery.

Time Frame

Intra-operative

Title

Blood level of receptor of advanced glycation end-products (RAGE) protein

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.

Time Frame

Post-operative day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wanda Popescu, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nathan Clendenen, MD,MS

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale New Haven Hospital

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

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

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