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

This study is not yet open for participant recruitment.

Verified by Policlinico Hospital, April 2009

First Received: April 3, 2009 Last Updated: April 9, 2009 History of Changes

Sponsored by:	Policlinico Hospital
Information provided by:	Policlinico Hospital
ClinicalTrials.gov Identifier:	NCT00876473

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

MedlinePlus related topics: Gas

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	30
Study Start Date:	April 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (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 myophaty

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
Milan, Italy

Sponsors and Collaborators

Policlinico Hospital

Investigators

Principal Investigator:

Davide Chiumello, MD

Policlinico Hospital

More Information

No publications provided

Responsible Party:	Policlinico Hospital ( Davide Chiumello )
Study ID Numbers:	590
Study First Received:	April 3, 2009
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00876473 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Policlinico Hospital:

CPAP
Acute Respiratory Failure

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Lung Diseases

Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute Respiratory Distress Syndrome

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009