NCT00284102

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

2.2 years

First QC Date

January 30, 2006

Last Update Submit

September 24, 2008

Conditions

Acute Respiratory Distress Syndrome

Keywords

gas exchangedead spacerespiratory failureALI/ARDS patients

Outcome Measures

Primary Outcomes (1)

  • Gas exchange, dead space, respiratory mechanics

    5, 15, 30, 60 minutes from PEEP change

Study Arms (1)

1

EXPERIMENTAL

ALI/ARDS patients

Procedure: Mechanical ventilation

Interventions

Mechanical ventilationPROCEDURE

measurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O)

1

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ALI/ARDS patients requiring mechanical ventilation

You may not qualify if:

  • Hemodynamic instability
  • Barotrauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Hospital

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeRespiratory Insufficiency

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Davide Chiumello, MD

    Policlinico Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 30, 2006

First Posted

January 31, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

IT(1)