Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408272
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2022-09-09
Brief Title:
Eit in ArdS for Tcav Setting EAST Study
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAST
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None