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

• Sponsor: Policlinico Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00876473
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 57
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure	Procedure: CPAP system

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The CPAP in Patients Affected by Acute Respiratory Failure
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange [30 minutes]

Secondary Outcome Measures

1. Comfort of breathing [30 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Hemodynamic instability

• Barotrauma

• Severe myopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Policlinico Hospital	Milan		Italy

Sponsors and Collaborators

• Policlinico Hospital

Investigators

• Principal Investigator: Davide Chiumello, MD, Policlinico Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Davide Chiumello, MD, Policlinico Hospital
• ClinicalTrials.gov Identifier: NCT00876473
• Other Study ID Numbers: 590
• First Posted: Apr 6, 2009
• Last Update Posted: Apr 28, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Davide Chiumello, MD, Policlinico Hospital: CPAP; Acute Respiratory Failure
• Additional relevant MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome

Study Results

No Results Posted as of Apr 28, 2015