Early Application of CPAP in Hematologic (HEMOCPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507533
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : February 18, 2009
Azienda Ospedaliera San Giovanni Battista
Information provided by:
University of Turin, Italy

July 25, 2007
July 26, 2007
February 18, 2009
October 2005
November 2007   (Final data collection date for primary outcome measure)
mechanical ventilation and intubation
Same as current
Complete list of historical versions of study NCT00507533 on Archive Site
Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality
Same as current
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Early Application of CPAP in Hematologic
Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure
The purpose of this study is to evaluate the use of CPAP in the prevention of acute respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied preventively in hematological patients with high risk of ARF may reduce:need for intubations and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of ICU and hospital stay

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hematologic Disease
Procedure: Continuous positive airway pressure
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
Not Provided
November 2007   (Final data collection date for primary outcome measure)

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 .
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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University of Turin, Italy
Azienda Ospedaliera San Giovanni Battista
Principal Investigator: Squadrone Vincenzo, MD
University of Turin, Italy
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP