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

This study is currently recruiting participants.
Verified May 2013 by Policlinico Hospital
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00876473
First received: April 3, 2009
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 30
Study Start Date: April 2009
Estimated Study Completion Date: January 2014
Estimated 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

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876473

Contacts
Contact: Davide Chiumello, MD +39-02-5503-3237 chiumello@libero.it

Locations
Italy
Policlinico Hospital Recruiting
Milan, Italy
Contact: Davide Chiumello, MD     +39-02-5503-3237     chiumello@libero.it    
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Davide Chiumello, MD Policlinico Hospital
  More Information

No publications provided

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: May 15, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Policlinico Hospital:
CPAP
Acute Respiratory Failure

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

ClinicalTrials.gov processed this record on May 22, 2013