Pressure Opening With Electrical Impedance Tomography

Not Applicable

Recruiting

• Conditions: Acute Lung Injury; Acute Respiratory Distress Syndrome
• Interventions: Other: EIT monitoring

• Registration Number: NCT05825534
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-24
• Study Start: 2023-06-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EIT monitoring	EIT monitoring	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France