Text Size

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
  Purpose

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


Condition Intervention Phase
Hematologic Disease
 Procedure: Continuous positive airway pressure
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • mechanical ventilation and intubation

Secondary Outcome Measures:
  • Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality

Estimated Enrollment: 40
Study Start Date: October 2005
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 .
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507533

Locations
Italy
Università degli Studi Torino
Turin, Piemonte, Italy, 10100
Sponsors and Collaborators
University of Turin, Italy
Azienda Ospedaliera San Giovanni Battista
Investigators
Principal Investigator: Squadrone Vincenzo, MD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00507533     History of Changes
Other Study ID Numbers: CPAP-2-H
Study First Received: July 25, 2007
Last Updated: February 17, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Turin, Italy:
CPAP
Hematologic
Neutropenic
ARF

Additional relevant MeSH terms:
Hematologic Diseases
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013