CLINICAL TRIAL

Fraction of Inspired Oxygen for Lung Injury

Waitlist Available · 18+ · All Sexes · Louisville, KY

This study is evaluating whether a higher level of oxygen during surgery may help reduce the risk of lung injury.

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About the trial for Lung Injury

Eligible Conditions
Lung Injury · Pulmonary Complications · Wounds and Injuries

Treatment Groups

This trial involves 2 different treatments. Fraction Of Inspired Oxygen is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Fraction of Inspired Oxygen
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
is a safe and feasible option with a low complication rate Isolated selective on-pump CABG through median sternotomy is a safe and feasible option with a low complication rate. show original
If you are admitted to an intensive care unit after a heart attack, your chances of survival are much higher. show original
We cater for people from the ages of 18 to 75. show original
is normal A BMI from 20 to 39.9 is within the normal range. show original
ASA II/III
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to one week while in the hospital
Screening: ~3 weeks
Treatment: Varies
Reporting: up to one week while in the hospital
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to one week while in the hospital.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Fraction of Inspired Oxygen will improve 1 primary outcome and 4 secondary outcomes in patients with Lung Injury. Measurement will happen over the course of up to one week while in the hospital.

length of hospital stay
UP TO ONE WEEK WHILE IN THE HOSPITAL
time from surgery day to discharge from ICU
UP TO ONE WEEK WHILE IN THE HOSPITAL
length of mechanical ventilation
UP TO ONE WEEK WHILE IN THE HOSPITAL
time from skin closure to extubation
UP TO ONE WEEK WHILE IN THE HOSPITAL
length of postoperative ICU stay
UP TO ONE WEEK WHILE IN THE HOSPITAL
time from ICU entry to discharge from ICU
UP TO ONE WEEK WHILE IN THE HOSPITAL
arterial PO2/FiO2 Ratio
48HR POST OPERATION
minimal postoperative arterial PO2/FiO2 Ratio
48HR POST OPERATION
Pulmonary complications
UP TO ONE WEEK WHILE IN THE HOSPITAL
ARDS, noncardiogenic pulmonary edema, pulmonary infection, pneumonia, pleural effusion, atelectasis, and respiratory failure are secondary endpoints
UP TO ONE WEEK WHILE IN THE HOSPITAL

Who is running the study

Principal Investigator
J. H.
Jiapeng Huang, Principal Investigator
University of Louisville

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for lung injury?

A significant proportion of lung injury cases remain uninvestigated or are classified by their etiologies and presentations as having unknown causes. Some cases of lung injury are treated with antibiotics, anti-inflammatories, respiratory therapies, or physical therapy, mostly without evidence-based clinical practice guidelines. In addition, some patients have been hospitalized over years owing to the diagnostic difficulty in this field. No comprehensive, evidence-based clinical practice guidelines on lung injury management have been developed.

Anonymous Patient Answer

Can lung injury be cured?

Lung injury, if untreated, will often result in pulmonary fibrosis and chronic obstructive pulmonary disease. Treatments have been developed at this time that have been shown to be effective in reducing the complications in both patients and in vitro. These are being evaluated in clinical trials at this time. There is no guarantee, however, that treatment will prevent the late progression to chronic obstructive lung disease, or that these treatments will reduce symptoms long-term in any specific population, and thus the question of whether lung injury can be cured is no longer relevant as treatment options have changed dramatically.

Anonymous Patient Answer

What causes lung injury?

All inhaled toxins cause direct, tissue injury. Aspiration of stomach acid also results in direct damage to the esophagus, and the presence of gastric acid implies an increased propensity for aspiration. Damage may occur when inhalation of acid in conjunction with aspiration of stomach acid causes tissue necrosis. A further complication of acid aspiration is that, in severe form, the lung responds by proliferating and growing into an enlarged tissue mass, which can obstruct the airway and cause airway obstruction. Acid aspiration can also be associated with esophagitis, a complication of alcohol and peptic ulcer disease. A definitive cause of aspiration cannot be identified in about 20 percent of cases.

Anonymous Patient Answer

What is lung injury?

It is important to understand the different mechanisms of lung injury. There are three main mechanisms of lung injury: 1) direct damage by infection; 2) immune-mediated damage by antibody and other immune effectors; and 3) inflammatory processes.

Anonymous Patient Answer

What are the signs of lung injury?

Signs of lung injury include increased respiratory rate, shortness of breath, a hoarse voice, decreased oxygen saturation and a rapid heart rate. Signs of lung injury are common in patients with sepsis.

Anonymous Patient Answer

How many people get lung injury a year in the United States?

Around 5.7 million people in the USA are hospitalized each year, for primary or secondary diagnoses of lung injury. This would be a significant increase if you take into account the high rate of undiagnosed lung disease and asymptomatic pulmonary fibrosis, which would be more common and more severe in this population. Lung injury is estimated to cause 5.9 million days in outpatient and inpatient hospitalization per year in the USA alone. For comparison, 3 million new cancer cases are estimated to occur a year. This is a large increase that is more than seven times larger than all projected yearly diagnoses of lung cancer.

Anonymous Patient Answer

How does fraction of inspired oxygen work?

Inappropriate ventilation is associated with increased risk of pulmonary complications in ventilated patients. Using a FiO2 at a level that is thought to be safe for non-ventilated patients is likely to increase risk in critically ill patients as well.

Anonymous Patient Answer

Is fraction of inspired oxygen safe for people?

Oxygen fractions of up to 100% appear to be safe and should be administered to people who do not breathe spontaneously or in whom the use of positive pressure ventilation is contraindicated during the acute phase of illness.

Anonymous Patient Answer

What is the latest research for lung injury?

All of the above studies provide significant insight into the pathological and molecular mechanisms of pulmonary injury. A great challenge to lung pathologists is to find a practical, clinically applicable approach, enabling detection of early disease in patients requiring the most effective therapeutic options and possibly improving survival.

Anonymous Patient Answer

How serious can lung injury be?

A major complaint of the patients suffering from bronchiolitis obliterans was increased airflow resistance, implying that their lung function had been affected. Even after the patients were treated, they were still affected by the condition, indicating that this condition could be long-lasting. The diagnosis and treatment of bronchiolitis obliterans deserve more attention. If we are to effectively treat this new condition, we need to develop new treatment strategies and new treatments at the same time.

Anonymous Patient Answer

Have there been other clinical trials involving fraction of inspired oxygen?

There are few clinical trials in the literature that have involved Fio2 in the treatment of post-thoracotomy patients with acute pulmonary edema. We highlight these trials by discussing their design and results, the rationale for their use of Fio2, the use of Fio2 in post-thoracotomy patients and the benefits and risks, and the lack of evidence to support the use of Fio2 in post-thoracotomy patients with acute pulmonary edema. Results from a recent clinical trial demonstrate that Fio2 is not suitable as a monotherapy in patients with post-thoracotomy pulmonary edema and may increase oxygen desaturation.

Anonymous Patient Answer

What is the primary cause of lung injury?

Most patients with severe COPD have evidence of lung injury, which is likely due to chronic inflammation and remodeling. There were higher levels of total and high-mobility group-1 protein in BAL fluid in patients with more severe chronic airflow obstruction but not in patients with less severe COPD.

Anonymous Patient Answer
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