Clinical trial NCT00263146: 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
Overall status: TERMINATED
Phase: NA
Conditions: Acute Lung Injury
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2005-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: proteasis activity as measured in broncho alveolar fluid (BAL)
measure: pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood.
Secondary outcomes:
measure: gaz exchange
measure: respiratory mechanics
measure: systemic hemodynamics
measure: visceral dysfunction scores.
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
affiliation: University Hospital of Tours
name: Gilles Rival, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Tours
name: Pierre-Francois Dequin, MD, PhD
role: STUDY_CHAIR
affiliation: Inserm U-618
name: Francis Gauthier, PhD
role: STUDY_DIRECTOR
References: