EIT Assessment of Overdistension in ARDS Patients in Prone Position (DISTIE-DV)

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

Mechanical ventilation in ARDS requires protective ventilation with low VT and PEEP. PEEP titration can improve lung recruitment in the dependent lung but with a risk of overdistension in the non-dependant lung. EIT can measure the distribution of tidal ventilation and assess overdistension and collapse during a PEEP titration in any position (prone or not).

This study aims to measure the best PEEP as a compromise between recruitment and overdistension during a PEEP trial with EIT before and just after PP.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Other: Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Benjamin REPUSSEAU, Dr; Phone Number: +33 05 57 65 68 66; Email: benjamin.repusseau@chu-bordeaux.fr

Study Locations

• France
  • Bayonne, France, 64000
    • Recruiting
    • CH Côte Basque
    • Contact: Hadrien ROZE, Pr; Phone Number: +33 0559443612; Email: hroze@ch-cotebasque.fr
  • Pessac, France, 33604
    • Recruiting
    • Hopital Haut-Leveque
    • Contact: Benjamin REPUSSEAU, Dr; Phone Number: +33 05 57 65 68 66; Email: benjamin.repusseau@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalised in the thoracic intensive care unit, with moderate or severe ARDS according to the Berlin criteria, requiring a prone position, treated with PP equipped with EIT, will be included.

Description

Inclusion Criteria:

• Patients hospitalized in the ICU and who suffered moderate or severe ARDS (Berlin criteria, PaO2/FiO2<150), intubated sedated, under myorelaxant 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study group; Patients with moderate or severe ARDS treated with PP equipped with EIT will be included. Measurement of EIT data and ventilator spirometry in supine position and just after turning the patient in PP during a decremental PEEP-EIT titration, will be done, and blood gases and finally haemodynamic data

Other: Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT); Positive End-Expiratory Pressure (PEEP) will be titrated with PEEP-EIT method as it is already done in usual care. A classical low flow Pression Volume (PV) curve will be done in order to detect airway closure and measure compliance, the acquisition of EIT data during PV curve will be analysed secondary with a dedicated software. Reconstruction of EIT derived PV curve will determine the regional airway opening pressures and compliances of the 2 lungs. Two decremental PEEP-EIT titrations will be compared, one in supine and the other just after turning in prone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of distension	Assessing the level of distension when titrating the optimal PEEP in the supine position (SP) and in the PP position the first and second day of ARDS in PP. The measure will be obtained thanks to the crossing in EIT of the overdistension curve and the collapse curve when the PEEP is reduced from 20 to 5 cmH2O.	48 hours after inclusion day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repartition of regional ventilation in each part of the lungs.	Thanks to PV-EIT curve, the measurement of regional Airway Opening Pressure (anterior vs posterior) will be evaluate (lower inflection point of the PV-EIT curve).	48 hours after inclusion day
Comparison of the percent of overdistension and collapse during the EIT-PEEP titration	Thanks to PEEP-EIT titration in PP and SP the percent of collapse and global over-distension in EIT will be evaluate.	48 hours after inclusion day

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Prone Position; Electrical Impedance Tomography; Ventilation Induced Lung Injury; Pressure Volume curve; lung collapse; lung overdistension
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome; Pulmonary Atelectasis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Posture; Therapeutics; Prone Position
• Other Study ID Numbers: CHUBX 2022/13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No