Eit in ArdS for Tcav Setting (EAST Study)

ARDS Clinical Trial

— EAST  

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408272
• Other study ID #: 2022PI097
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: Central Hospital, Nancy, France
• Contact: Matthieu KOSZUTSKI, MD
• Phone: +33383153851
• Email: m.koszutski[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• ARDS

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of overdistanded units	Percentage of overdistanded units measured at increasing levels of Phigh	through study completion an average of 1 day