Clinical trial NCT04352725: Effect of PEEP Titration on the EELV Measured by the Nitrogen Dilution Technique in ARDS
Official title: Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: respiratory distress
titration
end-expiratory
Lead sponsor: Centre Hospitalier Intercommunal Aix-Pertuis
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS
timeFrame: 1 day
Secondary outcomes:
measure: Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP
timeFrame: 1 day
measure: Analyzing the effect of PEEP titration on static compliance and dynamic strain
timeFrame: 1 day
measure: Effect of PEEP titration on hematosis via the calculation of the Pao2/Fio2 ratio for each PEEP step thanks to the measurement of Pao2 on arterial gasometry
timeFrame: 1 day
measure: Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)
timeFrame: 1 day
measure: Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)
timeFrame: 1 day
measure: Evaluate the hemodynamic tolerance of this procedure with the mean arterial pressure obtained by invasive blood pressure, noradrenaline dosage variation per procedure, lactate (obtained by arterial blood gas)
timeFrame: 1 day
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Centre Hospitalier Intercommunal Aix-Pertuis
Study officials:
affiliation: Centre Hospitalier Intercommunal Aix-Pertuis
name: Laurent LEFEBVRE, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.