The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy
NCT ID: NCT02509182
Last Updated: 2018-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2016-12-31
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intra-operative Inspiratory Oxygen Fraction and Postoperative Respiratory Complications
NCT02399878
Titration of Inspired Oxygen to Decrease the Incidence of Postoperative Pulmonary Complications
NCT06243146
Hyperbaric Oxygen Therapy for Lung Transplantation
NCT02363959
Assessment of the Efficacy of Tracheal Oxygen Administration During Bronchoscopy - a Phase II Trial
NCT01786642
Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure
NCT02464696
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
100% FiO2
100% oxygen administered during pulmonary lobectomy surgery.
100% oxygen
An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.
60% FiO2
60% oxygen administered during pulmonary lobectomy surgery.
60% oxygen
An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
60% oxygen
An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.
100% oxygen
An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wanda Popescu, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Nathan Clendenen, MD,MS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale New Haven Hospital
New Haven, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1507016157
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.