Eit in ArdS for Tcav Setting (EAST Study)
EAST
Electrical Impedance Tomography (EIT) for the Setting of High-pressure in Patients With Acute Respiratory Distress Syndrome (ARDS) on Time Controlled Adaptive Ventilation (TCAV).
1 other identifier
observational
12
1 country
1
Brief Summary
Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure. The therapeutic management is currently based on the treatment of the cause of ARDS, and on mechanical ventilation with positive expiratory pressure (PEEP). Another strategy that could be used is Time Controlled Adaptive Ventilation (TCAV) method based on ventilation using the airway pressure release ventilation (APRV) mode. Electrical impedance tomography (EIT) allows individual, non-invasive, real-time, bedside, radiation-free imaging of an anteroposterior section of the right and left lungs, with global and regional dynamic analyses. The aim of the study is to evaluate EIT for PHigh titration of TCAV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
May 10, 2024
CompletedStudy Start
First participant enrolled
June 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2024
CompletedMay 10, 2024
May 1, 2024
2 months
September 9, 2022
May 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of collapsed units on EIT
Percentage of collapsed lung areas measured at increasing levels of Phigh
through study completion an average of 1 day
Secondary Outcomes (1)
Percentage of overdistanded units
through study completion an average of 1 day
Study Arms (1)
TCAV EIT
Patients with early ARDS, \< 72h of Mechanical ventilation, under TCAV since one hour with EIT.
Eligibility Criteria
Patients with early moderate to severe ARDS under mechanical ventilation
You may qualify if:
- Moderate to severe ARDS patients with more than 24 hours of mechanical ventilation
- Under sedation with a Richmond Rating Scale less than or equal to -2.
You may not qualify if:
- Patients with a pacemaker or automatic implantable defibrillator
- Pregnant women.
- Contraindications to chest belt placement (e.g., spinal or thoracic recent surgery)
- Undrained pneumothorax, broncho-pleural fistula
- Hemodynamic instability (i.e., use of vasopressors at \> 2 ug.kg.min of norepinephrine)
- Patients on mechanical ventilation during more than 7 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Régional Universitaire de Nancy
Nancy, 54500, France
Study Officials
- PRINCIPAL INVESTIGATOR
Matthieu KOSZUTSKI, MD
CHRU Nancy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2022
First Posted
May 10, 2024
Study Start
June 1, 2024
Primary Completion
July 30, 2024
Study Completion
July 30, 2024
Last Updated
May 10, 2024
Record last verified: 2024-05