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

Primary Purpose

Acute Respiratory Distress Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

End-expiratory lung volume measurement and incremental PEEP titration

About this trial

This is an interventional supportive care trial for Acute Respiratory Distress Syndrome focused on measuring respiratory distress, titration, end-expiratory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Hospitalier Intercommunal Aix-PertuisRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

experimental procedure

Arm Description

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

Outcomes

Primary Outcome Measures

Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS

Secondary Outcome Measures

Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP

Analyzing the effect of PEEP titration on static compliance and dynamic strain

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

Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)

Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)

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)

Full Information

NCT ID

NCT04352725

First Posted

April 16, 2020

Last Updated

April 16, 2020

Sponsor

Centre Hospitalier Intercommunal Aix-Pertuis

1. Study Identification

Unique Protocol Identification Number

NCT04352725

Brief Title

Effect of PEEP Titration on the EELV Measured by the Nitrogen Dilution Technique in ARDS

Acronym

TIPEX-VOLTEX

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

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 20, 2020 (Actual)

Primary Completion Date

November 30, 2020 (Anticipated)

Study Completion Date

November 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Intercommunal Aix-Pertuis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Distress Syndrome

Keywords

respiratory distress, titration, end-expiratory

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental procedure

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

End-expiratory lung volume measurement and incremental PEEP titration

Intervention Description

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

Primary Outcome Measure Information:

Title

Observe end-expiratory lung volume change during an increasing PEEP titration procedure in patients with moderate to severe ARDS

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Define a threshold of end-expiratory lung volume variation to help determine optimal PEEP

Time Frame

1 day

Title

Analyzing the effect of PEEP titration on static compliance and dynamic strain

Time Frame

1 day

Title

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

Time Frame

1 day

Title

Study the correlation between % change in end-expiratory lung volume and improvement in hematosis (Pao2/Fio2)

Time Frame

1 day

Title

Compare end-expiratory lung volume variations according to the type of ARDS (severity, focal or diffuse, pulmonary or extra-pulmonary etiology)

Time Frame

1 day

Title

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Agathe BOULANT

Phone

0442335650

Ext

+33

aboulant@live.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurent LEFEBVRE, Dr.

Organizational Affiliation

Centre Hospitalier Intercommunal Aix-Pertuis

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Intercommunal Aix-Pertuis

City

Aix-en-Provence

ZIP/Postal Code

13100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agathe BOULANT

Phone

0442335650

Ext

+33

aboulant@live.fr

First Name & Middle Initial & Last Name & Degree

Thibault HELBERT, Dr.

First Name & Middle Initial & Last Name & Degree

Luc RODRIGUEZ, Dr.

First Name & Middle Initial & Last Name & Degree

Laurent LEFEBVRE, Dr.

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26645226

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.

Results Reference

background

PubMed Identifier

11549535

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.

Results Reference

background

PubMed Identifier

15976233

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.

Results Reference

background

PubMed Identifier

28146639

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

Results Reference

background

PubMed Identifier

21866369

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.

Results Reference

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Effect of PEEP Titration on the EELV Measured by the Nitrogen Dilution Technique in ARDS

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