Pressure Opening With Electrical Impedance Tomography (POET)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury
• Intervention / Treatment: Other: EIT monitoring

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurent Brochard, MD; Phone Number: 5686 416-864-6060; Email: laurent.brochard@unityhealth.to
• Study Contact Backup: Name: Clément Brault, MD; Phone Number: 03 22 08 89 09; Email: brault.clement@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • Recruiting
    • CHU Amiens
    • Principal Investigator: Laurent Brochard, MD
    • Contact: Clement Brault, MD
    • Principal Investigator: Lu Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: EIT monitoring

Other: EIT monitoring; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
prevalence of regional airway closure	1 year
prevalence of complete airway closure	1 year
Difference of global AOP values between EIT-derived method and the highest regional AOP	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Acute Respiratory Distress Syndrome; Acute Lung Injury; airway closure; airway opening pressure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: PI2022_843_0159

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