Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07090460

Pulmonary Overdistension Assessment With Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrom in Prone Position.

Mechanical ventilation in COPD requires a good interaction Patient-Ventilator without asynchronies in order to reduce mortality. Dynamic hyperinflation with PEEPi is responsible for major asynchronies in COPD. It is supposed to be symmetrical between the 2 lungs with the same PEEPi. EIT can measure the distribution of tidal ventilation and interlung lung insufflation delay on the impedance time curve of each lung. Moreover, it is possible in intubated COPD patients to assess one lung PEEPi during low flow insufflation with pressure-EIT monitoring.

This study aims to measure interlungs insufflation delay under mechanical ventilation in COPD patients

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Côte Basque

Bayonne, Centre Hospitalier de La Côte Basque, 64109, France

Location status: Recruiting

Location contact

Hadrien ROZE

PRINCIPAL_INVESTIGATOR

Séverine LABARRERE

CONTACT

[email protected]

0559443828

About this study

Scientific justification: Moderate or severe COPD with respiratory acidosis requires mechanical ventilation whether it is non-invasive or after intubation. There is a risk of various asynchronies due to dynamic hyperinflation, and it has been shown that a high level of asynchronies can be associated with mortality. EIT can measure the regional distribution of tidal ventilation, and its timing. It can also measure unilateral Pressure-EIT curves with low inflection point representing PEEPi.

Strategy description: Patients with moderate or severe COPD treated with mechanical ventilation equipped with EIT will be included. EIT will be monitored during tidal ventilation and during PEEP titration by the attending physician as it is already done in our unit. In case of invasive ventilation (NIV failure), a classical low flow PV curve will be done in order to mesure one lung PEEPi. For that the acquisition of EIT data during the low flow PV curve will be analysed secondary with a dedicated software. Reconstruction of EIT derived PV curve will determine the regional PEEPi.

Follow up description:

  • Measurement of EIT data and ventilator spirometry during NIV initiation and PEEP titration.
  • Blood gases under NIV as usual
  • Hemodynamic data

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients hospitalized in the ICU and who suffered moderate or severe COP (Gold 3 and 4)), with respiratory acidosis under NIV or intubated, and equipped with EIT over the age of 18.

Exclusion criteria

  • Broncho-pleural leaks
  • Pregnant or breastfeeding woman.
  • Guardianship or curatorship
  • Deprived of liberty
  • No health insurance
  • Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.)
  • Contra indications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)

Treatment and study plan

Primary outcomes

  1. Assessing inter-lungs insufflation delay under NIV or invasive mechanical ventilation on the impedance-time curves without PEEP.

    Time frame: Only 1 visit

Secondary outcomes

  1. Assessing inter-lungs insufflation delay under NIV or invasive mechanical ventilation on the impedance-time curves with PEEP.

    Time frame: Only 1 visit

  2. Comparison of End Expiratory Lung Impedance with or without PEEP

    Time frame: Only 1 visit

  3. Post treatment analysis of EIT low flow PV curves in intubated sedated patients, measurement of each lung PEEPi

    Time frame: Only 1 visit

Study contacts

Contact information is provided by the study sponsor or research team.

Professor ROZE

CONTACT

[email protected]

+33559443535

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de la côte Basque

Other

Registry information

Acronym: Tomo-BPCO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.