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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2020-11-30

Brief Summary

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Mechanical ventilation of the patient with acute respiratory distress syndrome is one of the first therapies.

Detailed Description

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The application of positive end expiratory pressure is recommended but the question remains "How to set the best positive end-expiratory pressure (PEEP) level for each patient? ". Different titration techniques have been studied on oxygenation and respiratory mechanics parameters without reaching a consensus. Currently we have a module that is connected to the ventilator to collect the patient's lung volume. It will therefore allow us to optimize the settings of the ventilator and to set the best level of positive end-expiratory pressure "best peep" in order to individualize our treatment for each patient.

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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

Group Type EXPERIMENTAL

End-expiratory lung volume measurement and incremental PEEP titration

Intervention Type 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

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to intensive care with a diagnosis of moderate to severe ARDS in accordance with the Berlin criteria, i.e. a PAFI \<200 and PEEP \>5cm H20 ratio
* Diagnosis of ARDS made within 72 hours
* Age over 18 years
* Informed consent of the patient and/or trusted person where applicable

Exclusion Criteria

* Start of mechanical ventilation more than 72 hours prior to inclusion.
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Aix-Pertuis

OTHER

Sponsor Role lead

Responsible Party

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Laurent LEFEBVRE

Doctor, rescuer

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Agathe BOULANT

Role: CONTACT

0442335650 ext. +33

Facility Contacts

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Agathe BOULANT

Role: primary

0442335650 ext. +33

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.

Reference Type BACKGROUND
PMID: 26645226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11549535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15976233 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28146639 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21866369 (View on PubMed)

Other Identifiers

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20192211-1

Identifier Type: -

Identifier Source: org_study_id

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