PEEP Test and Gas Exchange in ALI/ARDS Patients | NCT00284102

Studies
PEEP Test and Gas Exchange in ALI/ARDS Patients

NCT00284102

Sponsor

Policlinico Hospital

Status

Completed

Last Update Posted

Sep 25, 2008Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Acute Respiratory Distress Syndrome

Interventions

Mechanical ventilation

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

Sep 2008

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

Jan 2006

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jan 30, 2006

First Submission Date that Met QC Criteria

Jan 30, 2006

First Posted Date

Jan 31, 2006Estimated

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

Sep 24, 2008

Last Update Posted Date

Sep 25, 2008Estimated

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 investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on gas exchange.

Detailed Description

In a population of ALI/ARDS patients during mechanical ventilation we will evaluate the effect of different levels of PEEP on gas exchange and dead space.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	ALI/ARDS patients	Procedure: Mechanical ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mechanical ventilation	Procedure	measurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gas exchange, dead space, respiratory mechanics		5, 15, 30, 60 minutes from PEEP change

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ALI/ARDS patients requiring mechanical ventilation

Exclusion Criteria:

Hemodynamic instability
Barotrauma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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		20122	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012121	Respiration, Artificial

Ancestor Terms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D012151	Resuscitation
D004638	Emergency Treatment

Browse Leaves

Not provided

Browse Branches

Not provided