Early Application of CPAP in Hematologic

Hematologic Disease Clinical Trial

— HEMOCPAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507533
• Other study ID #: CPAP-2-H
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2007
• Last updated: February 17, 2009
• Start date: October 2005

Study information

• Verified date: February 2009
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hematologic Disease
• Hematologic Diseases

Intervention

Procedure:
• Continuous positive airway pressure

Locations

Country	Name	City	State
Italy	Università degli Studi Torino	Turin	Piemonte

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Azienda Ospedaliera San Giovanni Battista

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mechanical ventilation and intubation
Secondary	Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality