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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:
ClinicalTrials.gov Identifier:
NCT00263146
First Posted: December 7, 2005
Last Update Posted: January 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Tours
  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
Intervention Model: Parallel Assignment
Masking: Single
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
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00263146     History of Changes
Other Study ID Numbers: ARAMIS
First Submitted: December 5, 2005
First Posted: December 7, 2005
Last Update Posted: January 16, 2017
Last Verified: February 2010

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