- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00507533
Early Application of CPAP in Hematologic (HEMOCPAP)
Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Piemonte
-
Turin, Piemonte, Italy, 10100
- Università degli Studi Torino
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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mechanical ventilation and intubation
|
Secondary Outcome Measures
Outcome Measure |
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Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Squadrone Vincenzo, MD
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPAP-2-H
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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