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

January 10, 2018 updated by: Yale University

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

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 Overview

Status

Withdrawn

Conditions

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).

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 100% FiO2
100% oxygen administered during pulmonary lobectomy surgery.
An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.
Other Names:
  • FiO2 100%
Experimental: 60% FiO2
60% oxygen administered during pulmonary lobectomy surgery.
An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.
Other Names:
  • FiO2 60%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-operative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days
Mortality will be determined by accessing the medical record.
30 days
Mortality
Time Frame: 1 year
Mortality will be determined by accessing the medical record.
1 year
Hypoxemia less than 90%
Time Frame: Intra-operative
This will be recorded from the intraoperative data acquired during surgery.
Intra-operative
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.
Post-operative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Wanda Popescu, MD, Yale University
  • Principal Investigator: Nathan Clendenen, MD,MS, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 24, 2015

First Posted (Estimate)

July 27, 2015

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1507016157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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