Effect of PEEP Titration on the EELV Measured by the Nitrogen Dilution Technique in ARDS (TIPEX-VOLTEX)

Effect of Positive End Expiratory Pressure Titration on the End-expiratory Lung Volume Measured by the Nitrogen Dilution Technique in Acute Respiratory Distress Syndrome

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

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: End-expiratory lung volume measurement and incremental PEEP titration

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France, 13100
    • Recruiting
    • Centre Hospitalier Intercommunal Aix-Pertuis
    • Contact: Agathe BOULANT; Phone Number: +33 0442335650; Email: aboulant@live.fr
    • Sub-Investigator: Thibault HELBERT, Dr.
    • Sub-Investigator: Luc RODRIGUEZ, Dr.
    • Principal Investigator: Laurent LEFEBVRE, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP	1 day
Analyzing the effect of PEEP titration on static compliance and dynamic strain	1 day
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	1 day
Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)	1 day
Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)	1 day
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)	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Aix-Pertuis
• Investigators: Principal Investigator: Laurent LEFEBVRE, Dr., Centre Hospitalier Intercommunal Aix-Pertuis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Am J Respir Crit Care Med. 2018 Mar 1;197(5):684-685.

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: respiratory distress; titration; end-expiratory
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 20192211-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No