Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507533
Status:
COMPLETED
Last Update Posted:
2009-02-18
First Post:
2007-07-25
Brief Title:
Early Application of CPAP in Hematologic
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEMOCPAP
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 reduceneed for intubations and mechanical ventilation incidence of pneumonia and sepsismortalitylength 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 04 control or with oxygen at a FiO2 of 04 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 aa or respiratory rate more than 25 bpmCPAP 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
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 04 control or with oxygen at a FiO2 of 04 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 aa or respiratory rate more than 25 bpmCPAP 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None