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Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO (EIT-ECMO)

Primary Purpose

Severe ARDS

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultra-protective mechanical ventilation monitored by electrical impedance tomography
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Severe ARDS focused on measuring ECMO, ARDS, ultra-protective mechanical ventilation

Eligibility Criteria

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

Inclusion Criteria: aged ≥ 18 years patient with ARDS on venovenous (VV)-ECMO Written informed consent patient affiliated to a social security scheme Exclusion Criteria: Pregnancy Adult patient subject to a legal protection measure (tutor, curator, etc.) Patients with a pacemaker, automatic implantable cardioverter defibrillator, contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery) undrained pneumothorax, bronchopleural fistula hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

Sites / Locations

  • Service de médecine intensive - réanimation Hopital Pitié SalpêtrièreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional

Arm Description

All patients included

Outcomes

Primary Outcome Measures

cumulated collapse and overdistention percentages for each tidal volume by impedancemetry method
Estimating the "best" lung-compartment compliance, reflected by the number of functional lung units in that region, and current compliance for each pixel, the collapse and overdistention percentages per pixel will be compared for each tidal volume, with constant (pre-ECMO) PEEP.

Secondary Outcome Measures

Optimal PEEP by impedancemetry method at each tidal volume
PEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention at each tidal volume
cumulated collapsed and overdistended for each tidal volume by impedancemetry method with application of optimal PEEP
Estimating the "best" lung-compartment compliance, reflected by the number of functional lung units in that region, and current compliance for each pixel, the collapse and overdistention percentages per pixel will be compared for each tidal volume, with optimal PEEP

Full Information

First Posted
January 19, 2023
Last Updated
April 7, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05717218
Brief Title
Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO
Acronym
EIT-ECMO
Official Title
Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2023 (Actual)
Primary Completion Date
March 11, 2025 (Anticipated)
Study Completion Date
May 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
For ECMO supported patients with severe ARDS (acute respiratory distress syndrome), usual care include use of "ultraprotective" mechanical ventilation with tidal volume and pressure reductions that might ultimately enhance lung protection of patients with ARDS. Although very low tidal might also cause pulmonary derecruitment. The aim of this study is to monitor effects of very low tidal volume on regression of overdistension and derecruitment using electrical impedance tomography. Secondary aim is to describe the evolution of the optimal PEEP (Positive End Expiratory Pressure) during the decrease of the tidal volume
Detailed Description
Patients requiring venovenous ECMO support for severe ARDS will be monitored with electrical impedance tomography during introduction of "ultraprotective" mechanical ventilation. Monitoring will start with pre-ECMO ventilator setting, then the tidal volume will be lowered step by step. Other parameters of the ventilator will be kept constant. Then, cumulated collapse and overdistention percentages will be estimated for each tidal volume. Optimal tidal volume will be defined by the lowest sum of alveolar overdistension and collapse. Also, at the end of each step, PEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention. The aim is to determine whether the derecruitment induced by the decrease in tidal volume can be reduced by the application of PEP. Then, comparison of the different tidal volumes with application of ideal PEEP will be performed: measurement of the percentage of collapsed and overdistended areas by impedancemetry method between the different levels of tidal volume with application of ideal PEEP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe ARDS
Keywords
ECMO, ARDS, ultra-protective mechanical ventilation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
All patients included
Intervention Type
Device
Intervention Name(s)
Ultra-protective mechanical ventilation monitored by electrical impedance tomography
Intervention Description
A silicone EIT belt will be placed around the patient's thorax (sixth intercostal parasternal space). EIT data will be generated by application of a small alternating electrical current (5 mA at 50 kHz). Introduction of "ultraprotective" mechanical ventilation will be monitored.
Primary Outcome Measure Information:
Title
cumulated collapse and overdistention percentages for each tidal volume by impedancemetry method
Description
Estimating the "best" lung-compartment compliance, reflected by the number of functional lung units in that region, and current compliance for each pixel, the collapse and overdistention percentages per pixel will be compared for each tidal volume, with constant (pre-ECMO) PEEP.
Time Frame
One day
Secondary Outcome Measure Information:
Title
Optimal PEEP by impedancemetry method at each tidal volume
Description
PEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention at each tidal volume
Time Frame
One day
Title
cumulated collapsed and overdistended for each tidal volume by impedancemetry method with application of optimal PEEP
Description
Estimating the "best" lung-compartment compliance, reflected by the number of functional lung units in that region, and current compliance for each pixel, the collapse and overdistention percentages per pixel will be compared for each tidal volume, with optimal PEEP
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aged ≥ 18 years patient with ARDS on venovenous (VV)-ECMO Written informed consent patient affiliated to a social security scheme Exclusion Criteria: Pregnancy Adult patient subject to a legal protection measure (tutor, curator, etc.) Patients with a pacemaker, automatic implantable cardioverter defibrillator, contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery) undrained pneumothorax, bronchopleural fistula hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu Pr SCHMIDT
Phone
01 42 16 29 37
Email
matthieu.schmidt@aphp.fr
Facility Information:
Facility Name
Service de médecine intensive - réanimation Hopital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu Pr SCHMIDT
Phone
01 42 16 29 37
Email
matthieu.schmidt@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO

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