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).

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.

Study Overview

• Status: Not yet recruiting
• Conditions: ARDS

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.

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Benjamin PEQUIGNOT, MD; Phone Number: +33383153851; Email: b.pequignot@chru-nancy.fr
• Study Contact Backup: Name: Matthieu KOSZUTSKI, MD; Phone Number: +33383153851; Email: m.koszutski@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54500
    • Centre Hospitalier Régional Universitaire de Nancy
    • Contact: Matthieu Koszutski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with early moderate to severe ARDS under mechanical ventilation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
TCAV EIT; Patients with early ARDS, < 72h of Mechanical ventilation, under TCAV since one hour with EIT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of overdistanded units	Percentage of overdistanded units measured at increasing levels of Phigh	through study completion an average of 1 day

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Matthieu KOSZUTSKI, MD, CHRU Nancy

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ARDS; APRV; EIT; TCAV
• Other Study ID Numbers: 2022PI097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No