Lung InjuryNCT04115501
Intra-operative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
A study testing Fraction of Inspired Oxygen in people with Lung Injury and Pulmonary Complication, run by University of Louisville at 1 site in United States.
Trial summary
This study is a prospective observer blinded, central randomization controlled, multi-center clinical trial to assess the relationship between intraoperative FiO2 and postoperative pulmonary complications with lung injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Injury, Pulmonary Complication
- What is being tested?
- Fraction of Inspired Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2021to 1 Feb 2024
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75
- BMI from 20 to 39.9
- ASA II/III
- Undergoing isolated selective on-pump CABG through median sternotomy
- Subsequent admission to an intensive care unit (ICU).
Who cannot join
- with severe chronic obstructive pulmonary disease (COPD)
- Pregnant woman.
- With current acute coronary syndrome (<1 week)
- Severe anemia (hemoglobin <10g/L)
- Preoperative supplemental oxygen requirement to maintain arterial O2 of 92%,
- Right to left shunt in heart
Show all 13Show fewer
- Carotid stenosis defined as >50% stenosis of either carotid artery,
- Cardiac surgery that requires intraoperative circulatory arrest,
- Current use of dialysis,
- One-lung ventilation during surgery,
- Recent smoking (within 1 month),
- Non-respiratory reason to reintubate or delayed extubation such as bleeding or heart failure,
- Perioperative allogenic transfusion with red blood cell, plasma or platelet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
This study is a prospective observer blinded, central randomization controlled, multi-center clinical trial to assess the relationship between intraoperative FiO2 and postoperative pulmonary complications with lung injury.
Read the detailed description
Hyperoxia is common in cardiac surgery and is easy to prevent by adjusting FiO2. Since there is no prospective study on different FiO2 and postoperative pulmonary complications (PPCs) during cardiac surgery. We hypothesized that hyperoxia during cardiac surgery could lead to higher incidence of lung injury and PPCs than normoxia. The objective of this trial is to compare postoperative PPCs and other outcomes between hyperoxia and normoxia strategy by PaO2/FiO2 in CABG patients.
- Conditions
- Lung Injury, Pulmonary Complication
- Being tested
- Fraction of Inspired Oxygen
- Medical subject headings
- Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fraction of Inspired OxygenOther
Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| Restrictive Oxygen | Experimental | The restrictive oxygen patients' Fraction of Inspired Oxygen (FiO2) will be set at a minimum of 0.3 to maintain their oxygen saturations (SpO2) greater than or equal to 95% intraoperatively. During CPB a blended air/oxygen mixture will be titrated to arterial blood gas analysis with aim of maintenance of PaO2 between 100 and 150 mmHg. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation. Receives: Other: Fraction of Inspired Oxygen |
| Liberal Oxygen | No intervention | The liberal oxygen group will consist of subjects exposed to a Fraction of Inspired Oxygen (FiO2) set at 1.0 throughout the intraoperative period, including during cardiopulmonary bypass. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial PO2/FiO2 Ratio
minimal postoperative arterial PO2/FiO2 Ratio
Measured: 48hr post operation
Secondary outcomes (4)
Pulmonary complications
ARDS, noncardiogenic pulmonary edema, pulmonary infection, pneumonia, pleural effusion, atelectasis, and respiratory failure are secondary endpoints
Measured: up to one week while in the hospital
length of mechanical ventilation
time from skin closure to extubation
Measured: up to one week while in the hospital
length of postoperative ICU stay
time from ICU entry to discharge from ICU
Measured: up to one week while in the hospital
length of hospital stay
time from surgery day to discharge from ICU
Measured: up to one week while in the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start27 Feb 2021
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Why it stopped: inability to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung InjuryStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Tianjin Chest Hospital, Xiangya Hospital of Central South University, Guangdong Provincial People's Hospital, Second Xiangya Hospital of Central South University, Peking University People's Hospital
- Responsible party
- Principal investigator, Jiapeng Huang, University of Louisville
- Investigators
- Jiapeng Huang, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115501
- Sponsor's protocol ID
- 19.0988
- Status last verified
- Feb 2024
- First submitted
- 2 Oct 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery
- ClinicalTrials.gov ID
- NCT04115501
- Acronym / sponsor ID
- 19.0988
- Conditions
- Lung Injury, Pulmonary Complication
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: inability to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Tianjin Chest Hospital, Xiangya Hospital of Central South University, Guangdong Provincial People's Hospital, Second Xiangya Hospital of Central South University, Peking University People's Hospital
- Study start
- 27 Feb 2021 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 4 Oct 2019 (actual)
- 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.
This study is a prospective observer blinded, central randomization controlled, multi-center clinical trial to assess the relationship between intraoperative FiO2 and postoperative pulmonary complications with lung injury.
Detailed description
Hyperoxia is common in cardiac surgery and is easy to prevent by adjusting FiO2. Since there is no prospective study on different FiO2 and postoperative pulmonary complications (PPCs) during cardiac surgery. We hypothesized that hyperoxia during cardiac surgery could lead to higher incidence of lung injury and PPCs than normoxia. The objective of this trial is to compare postoperative PPCs and other outcomes between hyperoxia and normoxia strategy by PaO2/FiO2 in CABG patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restrictive Oxygen | Experimental | Other: Fraction of Inspired OxygenThe restrictive oxygen patients' Fraction of Inspired Oxygen (FiO2) will be set at a minimum of 0.3 to maintain their oxygen saturations (SpO2) greater than or equal to 95% intraoperatively. During CPB a blended air/oxygen mixture will be titrated to arterial blood gas analysis with aim of maintenance of PaO2 between 100 and 150 mmHg. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation. |
| Liberal Oxygen | No intervention | –The liberal oxygen group will consist of subjects exposed to a Fraction of Inspired Oxygen (FiO2) set at 1.0 throughout the intraoperative period, including during cardiopulmonary bypass. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from 18 to 75
- BMI from 20 to 39.9
- ASA II/III
- Undergoing isolated selective on-pump CABG through median sternotomy
- Subsequent admission to an intensive care unit (ICU).
Key exclusion criteria (13 listed)
- with severe chronic obstructive pulmonary disease (COPD)
- Pregnant woman.
- With current acute coronary syndrome (<1 week)
- Severe anemia (hemoglobin <10g/L)
- Preoperative supplemental oxygen requirement to maintain arterial O2 of 92%,
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 |
|---|---|---|
| Fraction of Inspired OxygenFraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass | Other | Restrictive Oxygen |
Primary outcome
arterial PO2/FiO2 Ratio
Time frame: 48hr post operation
minimal postoperative arterial PO2/FiO2 Ratio
4 secondary outcomes
Pulmonary complications
Time frame: up to one week while in the hospital
length of mechanical ventilation
Time frame: up to one week while in the hospital
length of postoperative ICU stay
Time frame: up to one week while in the hospital
length of hospital stay
Time frame: up to one week while in the hospital
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 15 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Jiapeng Huang, MD, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fraction of Inspired Oxygen in people with Lung Injury and Pulmonary Complication, run by University of Louisville 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 13 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 15 Feb 2024. 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.
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?
arterial PO2/FiO2 Ratio (time frame: 48hr post operation). 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 15 Feb 2024.