NCT04360590 - 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)

Blanch L, Villagra A, Sales B, Montanya J, Lucangelo U, Luján M, García-Esquirol O, Chacón E, Estruga A, Oliva JC, Hernández-Abadia A, Albaiceta GM, Fernández-Mondejar E, Fernández R, Lopez-Aguilar J, Villar J, Murias G, Kacmarek RM
Asynchronies during mechanical ventilation are associated with mortality. Intensive Care Med. 2015 Apr;41(4):633-41. doi: 10.1007/s00134-015-3692-6. Epub 2015 Feb 19.
Blokpoel RG, Burgerhof JG, Markhorst DG, Kneyber MC
Patient-Ventilator Asynchrony During Assisted Ventilation in Children. Pediatr Crit Care Med. 2016 May;17(5):e204-11. doi: 10.1097/PCC.0000000000000669.
Bordessoule A, Emeriaud G, Morneau S, Jouvet P, Beck J
Neurally adjusted ventilatory assist improves patient-ventilator interaction in infants as compared with conventional ventilation. Pediatr Res. 2012 Aug;72(2):194-202.
Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP
A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.
Pediatric Acute Lung Injury Consensus Conference Group
Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
Thille AW, Rodriguez P, Cabello B, Lellouche F, Brochard L
Patient-ventilator asynchrony during assisted mechanical ventilation. Intensive Care Med. 2006 Oct;32(10):1515-22. Epub 2006 Aug 1.

Pressure Support Ventilation (PSV) Versus Neurally Adjusted Ventilatory Assist (NAVA) in Difficult to Wean Pediatric ARDS Patients: a Physiologic Crossover Study

Details for clinical trial NCT04360590

Clinical trial NCT04360590 - References