Early Application of CPAP in Hematologic (HEMOCPAP)
Primary Purpose
Hematologic Disease
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Continuous positive airway pressure
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Disease focused on measuring CPAP, Hematologic, Neutropenic, ARF
Eligibility 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 .
Sites / Locations
- Università degli Studi Torino
Outcomes
Primary Outcome Measures
mechanical ventilation and intubation
Secondary Outcome Measures
Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality
Full Information
NCT ID
NCT00507533
First Posted
July 25, 2007
Last Updated
February 17, 2009
Sponsor
University of Turin, Italy
Collaborators
Azienda Ospedaliera San Giovanni Battista
1. Study Identification
Unique Protocol Identification Number
NCT00507533
Brief Title
Early Application of CPAP in Hematologic
Acronym
HEMOCPAP
Official Title
Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Turin, Italy
Collaborators
Azienda Ospedaliera San Giovanni Battista
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Disease
Keywords
CPAP, Hematologic, Neutropenic, ARF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Continuous positive airway pressure
Primary Outcome Measure Information:
Title
mechanical ventilation and intubation
Secondary Outcome Measure Information:
Title
Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Squadrone Vincenzo, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università degli Studi Torino
City
Turin
State/Province
Piemonte
ZIP/Postal Code
10100
Country
Italy
12. IPD Sharing Statement
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Early Application of CPAP in Hematologic
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