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

Phase 4

Withdrawn

• Conditions: Hyperoxia
• Interventions: Drug: 60% oxygen; Drug: 100% oxygen

• Registration Number: NCT02509182
• Lead Sponsor: Yale University

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).

Study Timeline

• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-24
• Study First Posted: 2015-07-27
• Study Start: 2016-12
• Primary Completion: 2017-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-12
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
60% FiO2	60% oxygen	60% oxygen administered during pulmonary lobectomy surgery.
100% FiO2	100% oxygen	100% oxygen administered during pulmonary lobectomy surgery.

Primary Outcome Measures

Name	Time	Method
PaO2 to FiO2 ratio	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.

Secondary Outcome Measures

Name	Time	Method
Blood level of receptor of advanced glycation end-products (RAGE) protein	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.
Mortality	1 year	Mortality will be determined by accessing the medical record.
Hypoxemia less than 90%	Intra-operative	This will be recorded from the intraoperative data acquired during surgery.

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States