Effect of PEEP Titration on the EELV Measured by the Nitrogen Dilution Technique in ARDS
NCT ID: NCT04352725
Last Updated: 2020-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-01-20
2020-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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experimental procedure
* end-expiratory lung volume measurement procedure according to the PEEP level set by the clinician, respecting a Vt at 6ml/kg IBW and Pplat\<28cmH2o
* incremental PEEP titration procedure in 5 steps starting from 5cmH2o up to 20cmH2o
End-expiratory lung volume measurement and incremental PEEP titration
* End expiratory lung volume measurement procedure according to the PEEP level set by the clinician, respecting a Vt at 6ml/kg IBW and Pplat\<28cmH2o
* incremental PEEP titration procedure in 5 steps starting from 5cmH2o up to 20cmH2o
Interventions
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End-expiratory lung volume measurement and incremental PEEP titration
* End expiratory lung volume measurement procedure according to the PEEP level set by the clinician, respecting a Vt at 6ml/kg IBW and Pplat\<28cmH2o
* incremental PEEP titration procedure in 5 steps starting from 5cmH2o up to 20cmH2o
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ARDS made within 72 hours
* Age over 18 years
* Informed consent of the patient and/or trusted person where applicable
Exclusion Criteria
* SDRA evolving for more than 72 hours
* Presence of major hemodynamic instability with mean blood pressure \<60mmhg, and/or heart rate \<45 bpm or \>150bpm with an increase in vasopressor amine dosage of more than 20% over the last 6 hours.
* Intracranial hypertension with CPP\<60mmhg
* Massive hemoptysis requiring immediate surgical or interventional radiology procedure
* Tracheal surgery (except intensive care tracheotomy) or sternotomy within the previous 15 days
* Trauma or surgery of the face in the previous 15 days.
* Deep vein thrombosis treated for less than 2 days
* Pacemaker implantation in the last 2 days
* Unstable fracture (spine, femur or pelvis)
* Respiratory reasons
* use of extracorporeal oxygenation
* nitric oxide
* pleural drainage system with bronchopleural gap
* pulmonary transplantation
* Poor respiratory tolerance per procedure with desaturation Spo2\<85%.
* Poor hemodynamic tolerability per procedure combining hypotension with MAP\<65mmhg and a 20% increase in norepinephrine dosage.
* Lack of patient consent to proceed
* minor patient
* lack of consent
18 Years
ALL
No
Sponsors
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Centre Hospitalier Intercommunal Aix-Pertuis
OTHER
Responsible Party
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Laurent LEFEBVRE
Doctor, rescuer
Principal Investigators
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Laurent LEFEBVRE, Dr.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Intercommunal Aix-Pertuis
Locations
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Centre Hospitalier Intercommunal Aix-Pertuis
Aix-en-Provence, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Casserly B, McCool FD, Saunders J, Selvakumar N, Levy MM. End-Expiratory Volume and Oxygenation: Targeting PEEP in ARDS Patients. Lung. 2016 Feb;194(1):35-41. doi: 10.1007/s00408-015-9823-6. Epub 2015 Dec 8.
Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.
Olegard C, Sondergaard S, Houltz E, Lundin S, Stenqvist O. Estimation of functional residual capacity at the bedside using standard monitoring equipment: a modified nitrogen washout/washin technique requiring a small change of the inspired oxygen fraction. Anesth Analg. 2005 Jul;101(1):206-12, table of contents. doi: 10.1213/01.ANE.0000165823.90368.55.
Sahetya SK, Goligher EC, Brower RG. Fifty Years of Research in ARDS. Setting Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1429-1438. doi: 10.1164/rccm.201610-2035CI.
Dellamonica J, Lerolle N, Sargentini C, Beduneau G, Di Marco F, Mercat A, Richard JC, Diehl JL, Mancebo J, Rouby JJ, Lu Q, Bernardin G, Brochard L. PEEP-induced changes in lung volume in acute respiratory distress syndrome. Two methods to estimate alveolar recruitment. Intensive Care Med. 2011 Oct;37(10):1595-604. doi: 10.1007/s00134-011-2333-y. Epub 2011 Aug 25.
Other Identifiers
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20192211-1
Identifier Type: -
Identifier Source: org_study_id
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