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

NCT02509182 | Withdrawn Phase 4 DMC

• 1 other identifier: 1507016157
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperoxia

Keywords

Hyperoxia; One-Lung Ventilation; Thoracic Surgery; Anesthesiology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mortality

  30 days

• Mortality

  1 year

• Hypoxemia less than 90%

  Intra-operative

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

  Post-operative day 1

Study Arms (2)

100% FiO2

ACTIVE COMPARATOR

100% oxygen administered during pulmonary lobectomy surgery.

Drug: 100% oxygen

60% FiO2

EXPERIMENTAL

60% oxygen administered during pulmonary lobectomy surgery.

Drug: 60% oxygen

Interventions

60% oxygen DRUG

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

Also known as: FiO2 60%

60% FiO2

100% oxygen DRUG

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

Also known as: FiO2 100%

100% FiO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Hyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Wanda Popescu, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Nathan Clendenen, MD,MS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: July 27, 2015
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

US (1)