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

This study has been completed.
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
First received: April 3, 2009
Last updated: April 27, 2015
Last verified: April 2015
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 Policlinico Hospital:

Primary Outcome Measures:
  • Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comfort of breathing [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

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
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients affected by Acute Respiratory Failure

Inclusion Criteria:

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

Exclusion Criteria:

  • Hemodynamic instability
  • Barotrauma
  • Severe myopathy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00876473

Policlinico Hospital
Milan, Italy
Sponsors and Collaborators
Policlinico Hospital
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 
Study First Received: April 3, 2009
Last Updated: April 27, 2015
Health Authority: Italy: Ministry of Health

Keywords provided by Policlinico Hospital:
Acute Respiratory Failure

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

ClinicalTrials.gov processed this record on May 25, 2016