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Sponsors and Collaborators: |
University of Turin, Italy Azienda Ospedaliera San Giovanni Battista |
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Information provided by: | University of Turin, Italy |
ClinicalTrials.gov Identifier: | NCT00507533 |
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 |
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Hematologic Disease |
Procedure: Continuous positive airway pressure |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure |
Estimated Enrollment: | 40 |
Study Start Date: | October 2005 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Mechanical ventilation criteria:
Italy, Piemonte | |
Università degli Studi Torino | |
Turin, Piemonte, Italy, 10100 |
Principal Investigator: | Squadrone Vincenzo, MD | unaffiliated |
Study ID Numbers: | CPAP-2-H |
Study First Received: | July 25, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00507533 History of Changes |
Health Authority: | Italy: Ethics Committee |
CPAP Hematologic Neutropenic ARF |
Hematologic Diseases |
Hematologic Diseases |