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Clinical Trials/NCT06408272
NCT06408272
Not yet recruiting
Not Applicable

Electrical Impedance Tomography (EIT) for the Setting of High-pressure in Patients With Acute Respiratory Distress Syndrome (ARDS) on Time Controlled Adaptive Ventilation (TCAV).

Central Hospital, Nancy, France1 site in 1 country12 target enrollmentJune 1, 2024
ConditionsARDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS
Sponsor
Central Hospital, Nancy, France
Enrollment
12
Locations
1
Primary Endpoint
Percentage of collapsed units on EIT
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
July 30, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Percentage of collapsed units on EIT

Time Frame: through study completion an average of 1 day

Percentage of collapsed lung areas measured at increasing levels of Phigh

Secondary Outcomes

  • Percentage of overdistanded units(through study completion an average of 1 day)

Study Sites (1)

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