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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on September 16, 2014