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Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure

Phase 4
18 Years
80 Years
Not Enrolling
Hematologic Disease

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Trial Information

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.

Inclusion Criteria:

- Neutropenic hematological patients ( less than 1000 leukocytes /mm3 ) .

- SaO2 less than 95% ( a.a.) ,

- Respiratory rate (RR ) more than 25 breaths/minute .

Exclusion Criteria:

- NYHA class II- III- IV or unstable angina or MI

- Valvular heart disease or cardiac surgery ( previous 3 months)

- Implanted cardiac pacemaker

- BMI less than 40

- History of dilated cardiomyopathy or CPE

- Severe COPD ( oxygen therapy , recent exacerbation, hypoxemic-hypercapnic to resting
, FEV1 < 50 %)

- Diagnosis of sleep or neuromuscular disorders.

- Claustrophobia .

- Mechanical ventilation criteria:

- Severe hypoxemia (arterial oxygen saturation < 80 % with maximal FiO2 )

- Ph < 7.3 with a PaCO2 > 50 mmHg

- Signs of patient distress with accessory muscle recruitment and paradoxal
abdomen movement

- RR > 35 breaths/minute .

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

mechanical ventilation and intubation

Principal Investigator

Squadrone Vincenzo, MD

Investigator Role:

Principal Investigator


Italy: Ethics Committee

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Hematologic Disease
  • CPAP
  • Hematologic
  • Neutropenic
  • ARF
  • Hematologic Diseases
  • Respiratory Insufficiency