Evaluation of Different Continuous Positive Airway Pressu... | NCT00876473

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

NCT00876473

Sponsor

Policlinico Hospital

Status

Completed

Last Update Posted

Apr 28, 2015Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Acute Respiratory Failure

Interventions

CPAP system

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

Apr 3, 2009

First Posted Date

Apr 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2015

Last Update Posted Date

Apr 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Acute Respiratory Failure patients	Procedure: CPAP system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP system	Procedure	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory mechanics, work of breathing, end-expiratory lung volume (EELV) and gas exchange		30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Comfort of breathing		30 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Hemodynamic instability
Barotrauma
Severe myopathy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients affected by Acute Respiratory Failure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Davide Chiumello, MD	Policlinico Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico Hospital		Milan			Italy