NCT06536543

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

July 26, 2024

Last Update Submit

January 13, 2026

Conditions

Acute Respiratory Distress Syndrome

Keywords

Ventilation Induced Lung Injurylung overdistensionlung collapseElectrical Impedance TomographyPressure Volume curveProne Position

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Comparison of the percent of overdistension and collapse during the EIT-PEEP titration

    48 hours after inclusion day

  • Repartition of regional ventilation in each part of the lungs.

    48 hours after inclusion day

Study Arms (1)

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)

Interventions

Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)OTHER

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.

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CH Cote Basque

Bayonne, 64000, France

RECRUITING

Hopital Haut-Lévêque

Pessac, 33604, France

RECRUITING

MeSH Terms

Conditions

Respiratory Distress SyndromePulmonary Atelectasis

Interventions

TherapeuticsProne Position

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Benjamin REPUSSEAU, Dr

CONTACT

05 57 65 68 66benjamin.repusseau@chu-bordeaux.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2024

First Posted

August 5, 2024

Study Start

October 15, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

FR(2)