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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 22, 2014