Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory Markers.
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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) |
- proteasis activity as measured in broncho alveolar fluid (BAL)
- pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood.
- 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 |
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| France | |
| University Hospital of Tours | |
| Tours, France, 37044 | |
| 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 Lung Diseases |
Respiratory Tract Diseases Respiration Disorders Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013