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Pressure Opening With Electrical Impedance Tomography (POET)

Primary Purpose

Acute Respiratory Distress Syndrome, Acute Lung Injury

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EIT monitoring
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Respiratory Distress Syndrome focused on measuring airway closure, airway opening pressure, Acute Respiratory Distress Syndrome, Acute Lung Injury

Eligibility Criteria

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

Inclusion Criteria: Adult patients (≥18 years old). Patients with PaO2/FiO2 ratio <300 mmHg. Volume- or pressure-controlled ventilation. Sedated, with or without infusion of neuromuscular blockage. Patients in supine position Exclusion Criteria: Pneumothorax and bronchopleural fistula. Severe hemodynamic instability (>30 % increase in vasopressors in the last 6 hours or norepinephrine > 0.5 µg/kg/min). PaO2/FiO2 ratio < 80 mmHg. Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 < 30 % predicted). Known or highly suspected elevated intracranial pressure (>18 mmHg). Impossibility to correctly position the EIT belt (e.g., burns chest drainage, etc.). Contraindications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions, etc.). Clinical judgement of the attending physician. Pregnant or breastfeeding woman Patient under guardianship, curators or safeguard of justice

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EIT monitoring

Arm Description

Outcomes

Primary Outcome Measures

prevalence of regional airway closure
prevalence of complete airway closure
Difference of global AOP values between EIT-derived method and the highest regional AOP

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
September 12, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05825534
Brief Title
Pressure Opening With Electrical Impedance Tomography
Acronym
POET
Official Title
Pressure Opening With Electrical Impedance Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Unity Health Toronto

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
Acute lung injury and ARDS (acute respiratory distress syndrome) are characterized by lung inhomogeneity, leading to a different distribution of the tidal volume (and pressure) within the lung. The quasi-static PV curve is a useful bedside tool to set mechanical ventilation, but it reflects a global behaviour of the lung. The electrical impedance tomography (EIT) is a non-invasive and radiation-free tool, monitoring dynamic changes in gas distribution. Images from EIT can be divided in several regions of interest, allowing to measure regional changes in compliance. The regional derived-EIT PV curve could provide valuable information on airway closure and AOP (airway opening pressure). Recent studies suggest that AOP measured by the ventilator seems to correspond to the AOP of the lowest injured lung. The investigators will perform one pressure-volume (PV) curve with a low-flow insufflation of 5 L/min starting from 0 cmH2O to a maximal airway pressure corresponding to the plateau pressure. During the low-flow insufflation, both ventilator and EIT-derived PV curves will be recorded. All PV curves will be analysed offline by the investigator to detect complete and regional airway closures, and measure AOPs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Lung Injury
Keywords
airway closure, airway opening pressure, Acute Respiratory Distress Syndrome, Acute Lung Injury

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
EIT monitoring
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
EIT monitoring
Intervention Description
EIT monitoring (PulmoVista 500, Dräger, Lübeck, Germany) will be applied using a dedicated silicon belt with 16 electrodes placed at the level of the fifth intercostal space. The EIT system will be connected to the ventilator and data of gas flow, volume, airway pressure, and impedance will be synchronously collected at 40 Hz. The investigators will perform one simple pressure-volume (PV) curve with a low-flow insufflation of 5 L/min starting from 0 cmH2O. During the low-flow insufflation, both ventilator and EIT-derived PV curves will be recorded. All PV curves will be analysed offline to detect complete and regional airway closures, and measure AOPs.
Primary Outcome Measure Information:
Title
prevalence of regional airway closure
Time Frame
1 year
Title
prevalence of complete airway closure
Time Frame
1 year
Title
Difference of global AOP values between EIT-derived method and the highest regional AOP
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (≥18 years old). Patients with PaO2/FiO2 ratio <300 mmHg. Volume- or pressure-controlled ventilation. Sedated, with or without infusion of neuromuscular blockage. Patients in supine position Exclusion Criteria: Pneumothorax and bronchopleural fistula. Severe hemodynamic instability (>30 % increase in vasopressors in the last 6 hours or norepinephrine > 0.5 µg/kg/min). PaO2/FiO2 ratio < 80 mmHg. Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 < 30 % predicted). Known or highly suspected elevated intracranial pressure (>18 mmHg). Impossibility to correctly position the EIT belt (e.g., burns chest drainage, etc.). Contraindications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions, etc.). Clinical judgement of the attending physician. Pregnant or breastfeeding woman Patient under guardianship, curators or safeguard of justice
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clément Brault, MD
Phone
03 22 08 89 09
Email
brault.clement@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Brochard, MD
Phone
416-864-6060
Ext
5686
Email
Laurent.brochard@unityhealth.to
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clement Brault, MD
First Name & Middle Initial & Last Name & Degree
Laurent Brochard, MD
First Name & Middle Initial & Last Name & Degree
Lu Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pressure Opening With Electrical Impedance Tomography

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