Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory Markers.

This study has been terminated.
(Lack of inclusion due to changed medical practice)
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT00263146
First received: December 5, 2005
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Acute Lung Injury
Procedure: recruitment maneuver

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

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.

Estimated Enrollment: 30
Study Start Date: September 2005
Estimated Study Completion Date: February 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263146

Locations
France
University Hospital of Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Gilles Rival, MD University Hospital of Tours
Study Chair: Pierre-Francois Dequin, MD, PhD University Hospital of Tours
Study Director: Francis Gauthier, PhD Inserm U-618
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00263146     History of Changes
Other Study ID Numbers: ARAMIS
Study First Received: December 5, 2005
Last Updated: February 2, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries

ClinicalTrials.gov processed this record on April 17, 2014