Acute Lung InjuryNCT00263146
Recruitment Maneuvers in ARDS: Effects on Respiratory Function and Inflammatory Markers.
A study testing recruitment maneuver in people with Acute Lung Injury, run by University Hospital, Tours at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury
- What is being tested?
- recruitment maneuver
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Jan 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- pregnancy
- obesity (BMI > 40 kg/M2)
- high probability of D-28 death
- severe burn injury
- severe hepatic cirrhosis (Child-Pugh C)
- aplasia
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
- Conditions
- Acute Lung Injury
- Being tested
- recruitment maneuver
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recruitment maneuverProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
proteasis activity as measured in broncho alveolar fluid (BAL)
pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood.
Secondary outcomes (4)
gaz exchange
respiratory mechanics
systemic hemodynamics
visceral dysfunction scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2006
- Study completionJan 2006
Why it stopped: Lack of inclusion due to changed medical practice
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Investigators
- Gilles Rival, MD, Principal investigator, University Hospital of ToursPierre-Francois Dequin, MD, PhD, Study chair, University Hospital of ToursFrancis Gauthier, PhD, Study director, Inserm U-618
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263146
- Sponsor's protocol ID
- ARAMIS
- Status last verified
- Feb 2010
- First submitted
- 5 Dec 2005
- Last updated
- 16 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00263146
- Acronym / sponsor ID
- ARAMIS
- Conditions
- Acute Lung Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion due to changed medical practice
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 7 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age over 18
- hospitalization in the ICU
- under mechanical ventilation
- Acute Lung Injury (ALI)criteria
- first week of ALI
Key exclusion criteria (15 listed)
- pregnancy
- obesity (BMI > 40 kg/M2)
- high probability of D-28 death
- severe burn injury
- severe hepatic cirrhosis (Child-Pugh C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recruitment maneuver | Procedure or surgery | – |
Primary outcome
proteasis activity as measured in broncho alveolar fluid (BAL)
pro- and antiinflammatory cytokines activity as measured in the BAL and in the blood.
4 secondary outcomes
gaz exchange
respiratory mechanics
systemic hemodynamics
visceral dysfunction scores.
Results and safety
The study was stopped early (reason given: Lack of inclusion due to changed medical practice). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Rival, MD principal investigator
University Hospital of Tours
Pierre-Francois Dequin, MD, PhD study chair
University Hospital of Tours
Francis Gauthier, PhD study director
Inserm U-618
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recruitment maneuver in people with Acute Lung Injury, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusion due to changed medical practice). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proteasis activity as measured in broncho alveolar fluid (BAL). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.