NCT02670460 - 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)

Gayan-Ramirez G
Ventilator-induced diaphragm dysfunction: time for (contr)action! Eur Respir J. 2013 Jul;42(1):12-5. doi: 10.1183/09031936.00076513.
Peñuelas O, Frutos-Vivar F, Fernández C, Anzueto A, Epstein SK, Apezteguía C, González M, Nin N, Raymondos K, Tomicic V, Desmery P, Arabi Y, Pelosi P, Kuiper M, Jibaja M, Matamis D, Ferguson ND, Esteban A; Ventila Group
Characteristics and outcomes of ventilated patients according to time to liberation from mechanical ventilation. Am J Respir Crit Care Med. 2011 Aug 15;184(4):430-7. doi: 10.1164/rccm.201011-1887OC.
Slutsky AS, Ranieri VM
Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. Review. Erratum in: N Engl J Med. 2014 Apr 24;370(17):1668-9.
Supinski GS, Callahan LA
Diaphragm weakness in mechanically ventilated critically ill patients. Crit Care. 2013 Jun 20;17(3):R120. doi: 10.1186/cc12792.

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial

Clinical trial NCT02670460 - References