Clinical trial NCT06408272: Eit in ArdS for Tcav Setting (EAST Study)
Official title: Electrical Impedance Tomography (EIT) for the Setting of High-pressure in Patients With Acute Respiratory Distress Syndrome (ARDS) on Time Controlled Adaptive Ventilation (TCAV).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ARDS
Keywords: ARDS
TCAV
EIT
APRV
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early moderate to severe ARDS under mechanical ventilation

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.

Detailed description: Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure with a mortality rate of up to 35% for the most severe forms. 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.

The TCAV method is based on a prolonged THigh set at a constant pressure, creating a continuous positive pressure phase associated with a brief release during a TLow allowing the elimination of carbon dioxide and the creation of an intrinsic PEEP. With long high pressure phase this method could result in better recruitment but could also expose the patient to overdistention. While the TLow setting is well defined, level of PHigh is not standardized.

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. Results of recent studies have highlighted the benefits of EIT, especially for ARDS patients in titrating PEEP in volume-controlled ventilation.

To date, no published study has evaluated EIT for PHigh titration using the TCAV method in patients with severe ARDS.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of collapsed units on EIT
timeFrame: through study completion an average of 1 day
Secondary outcomes:
measure: Percentage of overdistanded units
timeFrame: through study completion an average of 1 day
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
Study officials:
affiliation: CHRU Nancy
name: Matthieu KOSZUTSKI, MD
role: PRINCIPAL_INVESTIGATOR
References: