Early Application of CPAP in Hematologic

Phase 4

Completed

• Conditions: Hematologic Disease

• Registration Number: NCT00507533
• Lead Sponsor: University of Turin, Italy

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-07-25
• Study First Submitted QC: 2007-07-25
• Study First Posted: 2007-07-26
• Primary Completion: 2007-11
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mechanical ventilation and intubation

Secondary Outcome Measures

Name	Time	Method
Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality

Trial Locations

Locations (1)

Università degli Studi Torino; 🇮🇹 Turin, Piemonte, Italy