NCT01140750 - 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)

Dasgupta A, Rice R, Mascha E, Litaker D, Stoller JK
Four-year experience with a unit for long-term ventilation (respiratory special care unit) at the Cleveland Clinic Foundation. Chest. 1999 Aug;116(2):447-55.
Shen HN, Lin LY, Chen KY, Kuo PH, Yu CJ, Wu HD, Yang PC
Changes of heart rate variability during ventilator weaning. Chest. 2003 Apr;123(4):1222-8.
Varela M, Churruca J, Gonzalez A, Martin A, Ode J, Galdos P
Temperature curve complexity predicts survival in critically ill patients. Am J Respir Crit Care Med. 2006 Aug 1;174(3):290-8. Epub 2006 May 11.

Variability Analysis as a Predictor of Liberation From Mechanical Ventilation in Patients Admitted to the Respiratory Special Care Unit (ReSCU)

Clinical trial NCT01140750 - References