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Clinical Trials/NCT05825534
NCT05825534
Recruiting
Not Applicable

Pressure Opening With Electrical Impedance Tomography

Centre Hospitalier Universitaire, Amiens1 site in 1 country30 target enrollmentJune 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
30
Locations
1
Primary Endpoint
prevalence of regional airway closure
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 23, 2023
End Date
May 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

prevalence of regional airway closure

Time Frame: 1 year

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

Time Frame: 1 year

prevalence of complete airway closure

Time Frame: 1 year

Study Sites (1)

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