ARF Secondary to Cardiogenic Acute Pulmonary Oedema Clinical Trial
Official title:
Noninvasive Positive-pressure Ventilation (NPPV) for Acute Respiratory Failure in Out-of-hospital Patients: a Multicenter, Prospective, Randomized Controlled Trial
The purpose of this study is determine if NPPV can be performed in a pre-hospital setting very early after onset of dyspnea with a similar benefit in need of intubation and mortality as in previous study in hospital context and if early NPPV intervention have a real, rather standard medical therapy, value, both on objectively measured parameters and on patient's clinical status.
Noninvasive positive-pressure ventilation (NPPV) is increasingly being used in the care of
patients suffering acute respiratory failure. High-level evidence supports the use of NPPV
in this setting. With selected patients, NPPV decreases the rate of intubation, mortality
and nosocomial infections. NPPV obviates intubation in > 50 % of appropriately selected
patients. Both nasal and oronasal interfaces have been successfully used to apply NPPV, but
the oronasal (or facial) interface is often used for acute respiratory failure. Any
ventilator and ventilator mode can be used to apply NPPV, but in practice, portable pressure
ventilators and pressure-support mode are most commonly used.
In acute setting, this therapy must be applied as soon as possible after the onset of
problem. With our research team, we have demonstrated that NPPV can be used with success in
an emergency department. In our experience, when NPPV was early used, part of the patients
improved rapidly and was could be admitted to a general ward. An interesting fact is that
the time to improve clinical situation is short and we can postulated than NPPV application
in emergency department may be used as a "clinical triage". We have also demonstrated that
early application of bi-level NPPV to patients with acute respiratory failure due to acute
exacerbation of COPD or APO leads to a rapid improvement in clinical status and blood gases
that differs substantially from the evolution of similar patients treated with conventional
medical therapy and a placebo NPPV device.
Currently, we have very few data on the real utility to use of NPPV in Out-of-Hospital
patients with acute respiratory failure managed by medical team of pre-hospital care despite
the fact that this approach decreased the delay of application of a efficient ventilator
support. A prior study of Craven and coll. has demonstrated that NPPV helps relieve dyspnea
in patients with suspected congestive heart failure.
We can postulate that a shorter delay between onset of symptomatology and application of
NPPV increased the part of selected patient with good clinical outcome (intubation, need of
intensive care).
Comparisons :
Patients with COPD, APO with standard medical therapy + NPPV compared to patients with
standard medical therapy alone in pre-hospital setting.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment