HyperoxiaPhase 4NCT02509182
The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy
A Phase 4 study testing 60% oxygen and 100% oxygen in people with Hyperoxia, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperoxia
- What is being tested?
- 60% oxygen and 100% oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jul 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: 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.
Read the 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).
- Conditions
- Hyperoxia
- Being tested
- 60% oxygen, 100% oxygen
- Keywords
- Hyperoxia, One-Lung Ventilation, Thoracic Surgery, Anesthesiology
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60% oxygenDrug
Also called FiO2 60%
An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.
100% oxygenDrug
Also called FiO2 100%
An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| 100% FiO2 | Active comparator | 100% oxygen administered during pulmonary lobectomy surgery. Receives: Drug: 100% oxygen |
| 60% FiO2 | Experimental | 60% oxygen administered during pulmonary lobectomy surgery. Receives: Drug: 60% oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operative day 1
Secondary outcomes (4)
Mortality
Mortality will be determined by accessing the medical record.
Measured: 30 days
Mortality
Mortality will be determined by accessing the medical record.
Measured: 1 year
Hypoxemia less than 90%
This will be recorded from the intraoperative data acquired during surgery.
Measured: Intra-operative
Blood level of receptor of advanced glycation end-products (RAGE) protein
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.
Measured: Post-operative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startDec 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: Study never officially began
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperoxiaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wanda Popescu, MD, Principal investigator, Yale UniversityNathan Clendenen, MD,MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509182
- Sponsor's protocol ID
- 1507016157
- Status last verified
- Jan 2018
- First submitted
- 23 Jul 2015
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Decreasing the Inspired Oxygen Concentration on Post-Operative Oxygenation After Primary Lobectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02509182
- Acronym / sponsor ID
- 1507016157
- Conditions
- Hyperoxia
- Keywords
- Hyperoxia, One-Lung Ventilation, Thoracic Surgery, Anesthesiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never officially began
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 27 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100% FiO2 | Active comparator | Drug: 100% oxygen100% oxygen administered during pulmonary lobectomy surgery. |
| 60% FiO2 | Experimental | Drug: 60% oxygen60% oxygen administered during pulmonary lobectomy surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60% oxygenAlso: FiO2 60%An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery. | Drug | 60% FiO2 |
| 100% oxygenAlso: FiO2 100%An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery. | Drug | 100% FiO2 |
Primary outcome
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.
4 secondary outcomes
Mortality
Time frame: 30 days
Mortality
Time frame: 1 year
Hypoxemia less than 90%
Time frame: Intra-operative
Blood level of receptor of advanced glycation end-products (RAGE) protein
Time frame: Post-operative day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanda Popescu, MD principal investigator
Yale University
Nathan Clendenen, MD,MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 60% oxygen and 100% oxygen in people with Hyperoxia, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PaO2 to FiO2 ratio (time frame: Post-operative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.