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Pressure Opening With Electrical Impedance Tomography

Pressure Opening With Electrical Impedance Tomography

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05825534
Acronym
POET
Enrollment
6
Registered
2023-04-24
Start date
2023-09-05
Completion date
2023-12-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lung Injury, Acute Respiratory Distress Syndrome

Keywords

airway closure, airway opening pressure, Acute Respiratory Distress Syndrome, Acute Lung Injury

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.

Interventions

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.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER
Unity Health Toronto
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
prevalence of regional airway closure1 year
prevalence of complete airway closure1 year
Difference of global AOP values between EIT-derived method and the highest regional AOP1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026