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Completed

NCT Number: NCT05825534

Pressure Opening With Electrical Impedance Tomography

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.

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Key information

Conditions

Acute Respiratory Distress Syndrome Acute Lung Injury Lung Diseases Lung Injury Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EIT monitoring

Other

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 outcomes

  1. prevalence of regional airway closure

    Time frame: 1 year

  2. prevalence of complete airway closure

    Time frame: 1 year

  3. Difference of global AOP values between EIT-derived method and the highest regional AOP

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Unity Health Toronto

Registry information

Acronym: POET

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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