NCT03513809 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Brochard L
Ventilation-induced lung injury exists in spontaneously breathing patients with acute respiratory failure: Yes. Intensive Care Med. 2017 Feb;43(2):250-252. doi: 10.1007/s00134-016-4645-4. Epub 2017 Jan 10.
Mascheroni D, Kolobow T, Fumagalli R, Moretti MP, Chen V, Buckhold D
Acute respiratory failure following pharmacologically induced hyperventilation: an experimental animal study. Intensive Care Med. 1988;15(1):8-14.
Yoshida T, Fujino Y, Amato MB, Kavanagh BP
Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP. Re
Yoshida T, Uchiyama A, Fujino Y
The role of spontaneous effort during mechanical ventilation: normal lung versus injured lung. J Intensive Care. 2015 Jun 17;3:18. doi: 10.1186/s40560-015-0083-6. eCollection 2015. Review.

Spontaneous Breathing and Progression of Lung Injury in Acute Respiratory Distress Syndrome Before Connection to Mechanical Ventilation

Clinical trial NCT03513809 - References