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Inhaled Carbon Monoxide for Acute Respiratory Distress Syndrome (ARDS)
Study Summary
This trial will study inhaled carbon monoxide (iCO) as a potential treatment for ARDS, testing its safety, tolerability, and efficacy. The trial will be conducted at 7 tertiary care medical centers.
- Acute Respiratory Distress Syndrome (ARDS)
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You had a stroke or a heart attack very recently, or you are unable to think clearly after a heart attack.You are currently using a special type of ventilation called high frequency oscillatory ventilation.You must be willing to follow a specific breathing technique to protect your lungs.You have a serious injury to your airways from inhaling something harmful.You are extremely ill and not expected to live for another day.You have severe heart or lung disease that limits your daily activities.You have burns covering more than 40% of your body.You have difficulty breathing that is not caused by heart problems or excessive fluid in your body. A special test like echocardiography may be needed to confirm this.You have chest pain or use medication called nitrates for daily activities.You need a breathing tube and machine to help you breathe.You are currently using a machine called ECMO to help your heart or lungs function.It has been more than 7 days since you developed acute respiratory distress syndrome (ARDS).You are currently using inhaled medications to help relax your lungs' blood vessels.
- Group 1: Inhaled Carbon Monoxide
- Group 2: Medical air
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How extensive is the scope of this research project?
"This trial is currently not accepting new participants. Initially posted on July 1st 2019 and last amended August 22nd 2022, it has been supplanted by 1520 trials that are actively enrolling those with respiratory distress syndrome in newborns, as well as two studies involving inhaled Carbon Monoxide at 200 ppm being conducted simultaneously."
What aims are being sought by this research endeavor?
"Over the course of five days, this clinical trial's primary objective is to assess PaO2/FiO2 ratio on day 1-5 and 7. Secondary objectives include evaluating change in lipid mediators with LC-MS-MS based methods daily on days 1-3 and 5, as well as Sequential Organ Failure Assessment (SOFA) score taken on days 1-5, 7, 14 and 28."
To what extent have prior research studies explored the therapeutic efficacy of Inhaled Carbon Monoxide at 200 ppm?
"In 2019, Duke University Hospital initiated research on the effectiveness of Carbon Monoxide administered by inhalation at 200 ppm. This has since been followed up with 3 completed studies and 2 ongoing investigations taking place in Brooklyn, New york."
What health risks could someone incur when breathing in 200 parts per million of Carbon Monoxide?
"Power's rating of the safety profile for Inhaled Carbon Monoxide at 200 ppm is a 2. This judgement comes from their Phase 2 trial which has yielded some evidence of its security, but no proof that it works as intended."
How many centers are offering participation in the clinical trial?
"Patients are accepted at New york-Presbyterian Brooklyn Methodist Hospital in Brooklyn, NY; Weill Cornell Medical College in Manhattan, NY; Massachusetts General Hospital in Boston, MA and 7 more clinical sites."
Does this research project still have vacancies for participants?
"As of August 22nd, 2022 this trial has concluded its recruitment phase. It was initially posted on July 1st 2019 and is no longer accepting candidates. There are currently 1520 studies recruiting participants suffering from Respiratory Distress Syndrome (Newborn) as well as 2 trials for Inhaled Carbon Monoxide at 200 ppm that are open to applicants."
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