Pressure Opening With Electrical Impedance Tomography

NCT05825534 | Unknown

• 1 other identifier: PI2022_843_0159
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

EIT monitoring

EXPERIMENTAL

Other: EIT monitoring

Interventions

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.

EIT monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Unity Health Toronto: collaborator

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 39819779 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Central Study Contacts

Clément Brault, MD

CONTACT

03 22 08 89 09; brault.clement@chu-amiens.fr

Laurent Brochard, MD

CONTACT

416-864-6060; Laurent.brochard@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: June 23, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)