NCT01383213 - 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)

Confalonieri M, Potena A, Carbone G, Porta RD, Tolley EA, Umberto Meduri G
Acute respiratory failure in patients with severe community-acquired pneumonia. A prospective randomized evaluation of noninvasive ventilation. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1585-91.
Cosentini R, Brambilla AM, Aliberti S, Bignamini A, Nava S, Maffei A, Martinotti R, Tarsia P, Monzani V, Pelosi P
Helmet continuous positive airway pressure vs oxygen therapy to improve oxygenation in community-acquired pneumonia: a randomized, controlled trial. Chest. 2010 Jul;138(1):114-20. doi: 10.1378/chest.09-2290. Epub 2010 Feb 12.
Ferrer M, Esquinas A, Leon M, Gonzalez G, Alarcon A, Torres A
Noninvasive ventilation in severe hypoxemic respiratory failure: a randomized clinical trial. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1438-44. Epub 2003 Sep 18.
Squadrone V, Massaia M, Bruno B, Marmont F, Falda M, Bagna C, Bertone S, Filippini C, Slutsky AS, Vitolo U, Boccadoro M, Ranieri VM
Early CPAP prevents evolution of acute lung injury in patients with hematologic malignancy. Intensive Care Med. 2010 Oct;36(10):1666-74. doi: 10.1007/s00134-010-1934-1. Epub 2010 Jun 9.

A Prospective, Randomized, Controlled Trial to Evaluate the Efficacy of CPAP Delivered by Helmet in Comparison With Oxygen Therapy by Venturi Mask in Severe Acute Respiratory Failure Caused by Pneumonia

Details for clinical trial NCT01383213

Clinical trial NCT01383213 - References