Early Application of CPAP in Hematologic

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Hematologic Disease

Intervention / Treatment
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* Procedure: Continuous positive airway pressure


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Continuous positive airway pressure|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilation and intubation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, Hematologic, Neutropenic, ARF