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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00876473
First Posted: April 6, 2009
Last Update Posted: April 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
  Purpose
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 Intervention
Acute Respiratory Failure Procedure: CPAP system

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The CPAP in Patients Affected by Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Davide Chiumello, Policlinico Hospital:

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

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

Enrollment: 30
Study Start Date: April 2009
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


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.
  Eligibility

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 Submitted: April 3, 2009
First Posted: April 6, 2009
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


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