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RecruitingNCT07090460Tomo-BPCOUpdated Jun 1, 2026

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

An observational study in Acute Respiratory Distress Syndrome (ARDS), sponsored by Centre Hospitalier de la côte Basque. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Centre Hospitalier de la côte Basque · Observational

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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
02

Conditions studied

  • Acute Respiratory Distress Syndrome (ARDS)

Keywords

  • Chronic Obstructive Pulmonary Disease
  • Mechanical Ventilation
  • NIV
  • Asynchronies
  • Electrical Impedance Tomography
  • Pressure Impedance curve
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Centre Hospitalier de la côte Basque is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Acute Respiratory Distress Syndrom in prone position

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

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)
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Côte Basque
    Bayonne, Centre Hospitalier de La Côte Basque 64109, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07090460
Lead sponsor
Centre Hospitalier de la côte Basque
Responsible party
Dr Hadrien ROZE (Doctor, Centre Hospitalier de la côte Basque) — Principal investigator
First posted
Jul 29, 2025
Start date
Nov 22, 2025
Primary completion
Aug 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jun 1, 2026

Study contacts

Professor ROZE
Contact
hroze@ch-cotebasque.fr
+33559443535

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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