Pressure Opening With Electrical Impedance Tomography

NCT ID: NCT05825534

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-23
• Study Completion Date: 2024-05-31

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.

Conditions

Acute Respiratory Distress Syndrome; Acute Lung Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

EIT monitoring

Group Type: EXPERIMENTAL

EIT monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens

Amiens, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Clément Brault, MD

Role: CONTACT

brault.clement@chu-amiens.fr

03 22 08 89 09

Laurent Brochard, MD

Role: CONTACT

Laurent.brochard@unityhealth.to

416-864-6060 ext. 5686

Facility Contacts

Clement Brault, MD

Role: primary

References

Sun N, Brault C, Rodrigues A, Ko M, Vieira F, Phoophiboon V, Slama M, Chen L, Brochard L. Distribution of airway pressure opening in the lungs measured with electrical impedance tomography (POET): a prospective physiological study. Crit Care. 2025 Jan 16;29(1):28. doi: 10.1186/s13054-025-05264-3.

Reference Type: DERIVED

PMID: 39819779 (View on PubMed)

Other Identifiers

PI2022_843_0159

Identifier Type: -

Identifier Source: org_study_id