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

NCT07090460 | Recruiting

• 2 other identifiers: P-2025/012025-A00447-42
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Only 1 visit

Secondary Outcomes (3)

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

  Only 1 visit

• Comparison of End Expiratory Lung Impedance with or without PEEP

  Only 1 visit

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

  Only 1 visit

Eligibility Criteria

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

Study Population

Patients with Acute Respiratory Distress Syndrom in prone position

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier de la côte Basque: lead

Study Sites (1)

Centre Hospitalier Côte Basque

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

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Professor ROZE

CONTACT

+33559443535; hroze@ch-cotebasque.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr ROZE Hadrien

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: November 22, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)