EIT Assessment of Overdistension in ARDS Patients in Prone Position

Recruiting

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Other: Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)

• Registration Number: NCT06536543
• Lead Sponsor: University Hospital, Bordeaux

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-05
• Status Verified: 2024-10
• Study Start: 2024-10-15
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group	Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)	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

Primary Outcome Measures

Name	Time	Method
Level of distension	48 hours after inclusion day	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.

Secondary Outcome Measures

Name	Time	Method
Comparison of the % of overdistension and collapse during the EIT-PEEP titration	48 hours after inclusion day	Thanks to PEEP-EIT titration in PP and SP the % of collapse and global over-distension in EIT will be evaluate.
Assessment of prone position	48 hours after inclusion day	Comparison of the data between the first day of prone position and the second day.
Repartition of regional ventilation in each part of the lungs.	48 hours after inclusion day	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).

Trial Locations

Locations (1)

Hopital Haut-Lévêque; 🇫🇷 Pessac, France