Early Application of CPAP in Hematologic (HEMOCPAP)

This study has been completed.

Sponsor:

Collaborator:

Azienda Ospedaliera San Giovanni Battista

Information provided by:

University of Turin, Italy

ClinicalTrials.gov Identifier:

NCT00507533

First received: July 25, 2007

Last updated: February 17, 2009

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 25, 2007

Last Updated Date

February 17, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

mechanical ventilation and intubation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00507533 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Early Application of CPAP in Hematologic

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Hematologic Disease

Intervention ^ICMJE

Procedure: Continuous positive airway pressure

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 .

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT00507533

Other Study ID Numbers ^ICMJE

CPAP-2-H

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Turin, Italy

Collaborators ^ICMJE

Azienda Ospedaliera San Giovanni Battista

Investigators ^ICMJE

Principal Investigator:

Squadrone Vincenzo, MD

Information Provided By

University of Turin, Italy

Verification Date

February 2009

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

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