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Clinical Trials/NCT06536543
NCT06536543
Recruiting
Not Applicable

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

University Hospital, Bordeaux2 sites in 1 country20 target enrollmentOctober 15, 2024

Overview

Phase
Not Applicable
Intervention
Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)
Conditions
Acute Respiratory Distress Syndrome
Sponsor
University Hospital, Bordeaux
Enrollment
20
Locations
2
Primary Endpoint
Level of distension
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2024
End Date
May 1, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

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)

Arms & Interventions

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

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

Outcomes

Primary Outcomes

Level of distension

Time Frame: 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 Outcomes

  • Repartition of regional ventilation in each part of the lungs.(48 hours after inclusion day)
  • Comparison of the percent of overdistension and collapse during the EIT-PEEP titration(48 hours after inclusion day)

Study Sites (2)

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