The Effect of Decreasing the Inspired Oxygen Concentratio... | NCT02509182

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

NCT02509182

Sponsor

Yale University

Status

Withdrawn

Last Update Posted

Jan 12, 2018Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Hyperoxia

Interventions

60% oxygen
100% oxygen

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never officially began

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Jul 2017Estimated

Completion Date

Jul 2018Estimated

First Submitted Date

Jul 23, 2015

First Submission Date that Met QC Criteria

Jul 24, 2015

First Posted Date

Jul 27, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2018

Last Update Posted Date

Jan 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
60% oxygen	Drug	An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.	60% FiO2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mortality	Mortality will be determined by accessing the medical record.	30 days
Mortality	Mortality will be determined by accessing the medical record.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wanda Popescu, MD	Yale University	Principal Investigator
Nathan Clendenen, MD,MS	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale New Haven Hospital		New Haven	Connecticut	06510	United States

Condition Browse Module

MeSH Terms

ID	Term
D018496	Hyperoxia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010100	Oxygen

Ancestor Terms

ID	Term
D018011	Chalcogens
D004602	Elements
D007287	Inorganic Chemicals
D005740	Gases

Browse Leaves

Not provided

Browse Branches

Not provided