Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory Markers.
Primary Purpose
Acute Lung Injury
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
recruitment maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lung Injury
Eligibility Criteria
Inclusion Criteria: age over 18 hospitalization in the ICU under mechanical ventilation Acute Lung Injury (ALI)criteria first week of ALI hemodynamic stability (mAP > 75 mmHg since one hour) informed consent signed (patient or relatives) Exclusion Criteria: pregnancy obesity (BMI > 40 kg/M2) high probability of D-28 death severe burn injury severe hepatic cirrhosis (Child-Pugh C) aplasia HIV or CHV infection use of more than 0.5 mg/kg of steroïds immunosuppressor agents hemopathy contra indications for BAL contra indications for recruitment maneuvers baro-traumatism left cardiac failure chronic respiratory failure inclusion in another study during the past month
Sites / Locations
- University Hospital of Tours
Outcomes
Primary Outcome Measures
proteasis activity as measured in broncho alveolar fluid (BAL)
pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood.
Secondary Outcome Measures
gaz exchange
respiratory mechanics
systemic hemodynamics
visceral dysfunction scores.
Full Information
NCT ID
NCT00263146
First Posted
December 5, 2005
Last Updated
January 13, 2017
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT00263146
Brief Title
Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory Markers.
Official Title
Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory (ARAMIS: Apport d'un Recrutement Alveolaire Sur Les Marqueurs de l'Inflammation Dans le SDRA)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Terminated
Why Stopped
Lack of inclusion due to changed medical practice
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Acute Respiratory Distress Syndrom is associated to lung and systemic inflammation, which could be worsened by mechanical ventilation.This included a proteasis - antiproteasis imbalance which could participate to a fibrosis process.
Low tidal-volume ventilation (6 mL/kg) with low plateau pressure (< 30 cm H2O) has been proved to decrease mortality when compared with more conventionnal high-volume (12 mL/kg) ventilation.Moreover, this lung-protective approach decrease lung annd systemic inflammation.
Using recruitment maneuvers (i.e. the application during a short time of high pressures with the intention to re-open the lung, followed by an increase of PEEP-level to keep the lung open, in an attempt to decrease the alveolar shear-stress) has been proposed to improve oxygen and to reduce bio-trauma.
However, the effect of such maneuvers on the inflammatory response and on the evolution of ARDS remains unknown.
Therefore we have planned a randomized, monocentric, controlled trial consisting of the comparison of two approaches of mechanical ventilation in Acute Lung Injury. This trial will include 30 hemodynamically stable patients fulfilling the ALI or ARDS criteria defined by the US and European Consensus Conference.
They will be randomized in two groups: standard low-volume ventilation vs. recruitment maneuvers.
The main objective of our study is to compare both ventilatory strategies in termes of lung and systemic inflammation.
The primary outcome measures will be the proteasis activity as measured in broncho alveolar fluid (BAL) and pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood. Two samples (BAL and blood) will be obtained at a 48-72 hours interval. In the recruitment maneuver group, the first BAL will be obtained two hours before the maneuver.
Secondary outcome measures will be gaz exchange, respiratory mechanics, systemic hemodynamics and visceral dysfunction scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
recruitment maneuver
Primary Outcome Measure Information:
Title
proteasis activity as measured in broncho alveolar fluid (BAL)
Title
pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood.
Secondary Outcome Measure Information:
Title
gaz exchange
Title
respiratory mechanics
Title
systemic hemodynamics
Title
visceral dysfunction scores.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age over 18
hospitalization in the ICU
under mechanical ventilation
Acute Lung Injury (ALI)criteria
first week of ALI
hemodynamic stability (mAP > 75 mmHg since one hour)
informed consent signed (patient or relatives)
Exclusion Criteria:
pregnancy
obesity (BMI > 40 kg/M2)
high probability of D-28 death
severe burn injury
severe hepatic cirrhosis (Child-Pugh C)
aplasia
HIV or CHV infection
use of more than 0.5 mg/kg of steroïds
immunosuppressor agents
hemopathy
contra indications for BAL
contra indications for recruitment maneuvers
baro-traumatism
left cardiac failure
chronic respiratory failure
inclusion in another study during the past month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles Rival, MD
Organizational Affiliation
University Hospital of Tours
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre-Francois Dequin, MD, PhD
Organizational Affiliation
University Hospital of Tours
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Francis Gauthier, PhD
Organizational Affiliation
Inserm U-618
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
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Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory Markers.
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