Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure
Immunocompromised patients with a hematological malignancy that requiring admission in
intensive care unit (ICU) and subsequently mechanical ventilation for respiratory failure
was estimated between 20- 50 per cent of all admitted in hospital.
The survival rate of this patients that requiring mechanical ventilation is very poor.
In many cases the immunodepression with a great improvement in severe complication as
infections , pneumonia, sepsis , is the consequence of our therapy ( chemotherapy , bone
marrow transplantation and stem cell transplantation ) .
Pneumonia is very common cause of mechanical ventilation in about 45-74 per cent of the
all patient with acute respiratory failure (ARF) .
The trial was designed to enroll 40 patients in two groups to demonstrate reduction from
50% to 10 % of the need of mechanical ventilation , with a type I risk of error of 5% and a
power of 80 %.
Patients were randomized to be treated for four days Venturi mask at a FiO2 of 0.4 (control)
or with oxygen at a FiO2 of 0.4 plus a CPAP of 10 cm H2O (CPAP). At the end of the 4-days
period, patients passed a screening test breathing ambient air. Patients returned to the
assigned treatment if SaO2 less than 95% a.a or respiratory rate more than 25 bpm.CPAP was
generated using a flow generator with an adjustable inspiratory oxygen fraction set to
deliver a flow of up to 140 liters per minute (Whisperflow, Caradyne, Ireland) and a
spring-loaded expiratory pressure valve (Vital Signs Inc, Totoma NJ) and applied using a
latex-free polyvinyl chloride transparent helmet (CaStar, Starmed, Italy) (15); all centers
measured the inspiratory oxygen fraction using an oxygen analyzer (Oxicheck, Caradyne,
Ireland) through the Venturi mask or the helmet.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
mechanical ventilation and intubation
Squadrone Vincenzo, MD
Principal Investigator
Italy: Ethics Committee
CPAP-2-H
NCT00507533
October 2005
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