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Evaluation of Different Continuous Positive Airway Pressure (CPAP) Systems in Patients With Acute Respiratory Failure

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ClinicalTrials.gov Identifier: NCT00876473
Recruitment Status : Completed
First Posted : April 6, 2009
Last Update Posted : April 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to evaluate the performance, the tolerability and the efficacy on gas-exchange of different CPAP (Continuous Positive Airway Pressure) systems.

Condition or disease Intervention/treatment
Acute Respiratory Failure Procedure: CPAP system

Detailed Description:
Three CPAP systems are studied for each patient at the same level of PEEP: 1) continuous high-flow CPAP with fixed value PEEP valve; 2) continuous high-flow CPAP with Boussignac PEEP valve; 3) demand flow CPAP, supplied by a ventilator.

Study Design

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The CPAP in Patients Affected by Acute Respiratory Failure
Study Start Date : April 2009
Primary Completion Date : January 2014
Study Completion Date : January 2014


Groups and Cohorts

Group/Cohort Intervention/treatment
1
Acute Respiratory Failure patients
Procedure: CPAP system

Evaluating the effects of different CPAP systems on respiratory mechanics, respiratory effort and gas-exchange

CPAP systems:

Continuous high-flow CPAP with fixed value PEEP valve

Continuous high-flow CPAP with Boussignac valve

Demand flow CPAP supplied by ventilator



Outcome Measures

Primary Outcome Measures :
  1. Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Comfort of breathing [ Time Frame: 30 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients affected by Acute Respiratory Failure
Criteria

Inclusion Criteria:

  • Intubated-tracheostomized subjects receiving CPAP during the weaning from invasive mechanical ventilation

Exclusion Criteria:

  • Hemodynamic instability
  • Barotrauma
  • Severe myopathy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876473


Locations
Italy
Policlinico Hospital
Milan, Italy
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Davide Chiumello, MD Policlinico Hospital
More Information

Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00876473     History of Changes
Other Study ID Numbers: 590
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by Davide Chiumello, Policlinico Hospital:
CPAP
Acute Respiratory Failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases