A Comparison of Optimal PEEP Determination Guided by EIT and G5 Device in Moderate and Severe ARDS Patients

Study Overview
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Brief Summary
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To Select the Optimal Positive End-expiratory Pressure in Moderate and Severe Acute Respiratory Distress Syndrome Patients by Using: the novel Non-invasive Electrical Impedance Tomography Guided Method the Protective ventilation tool G5(MV)

Detailed Description
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To titrate PEEP guided by EIT. A global inhomogeneity (GI) index and regional compliance based on EIT were developed to quantify the tidal volume distribution within the lung. The aim of this study was to test the feasibility of optimizing PEEP with respect to ventilation homogeneity using the GI index and regional compliance. To titrate PEEP with the Protective Ventilation Tool by G5(MV). The new generation of ventilator will deliver an optimal PEEP on ARDS patients based on their status automatically.

Official Title
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A Comparison of Optimal Positive End-expiratory Pressure Determination Guided by Electrical Impedance Tomography and Protective Ventilation Tool by G5(MV) in Moderate and Severe Acute Respiratory Distress Syndrome Patients

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: optimal PEEP guided by EIT
* Device: optimal PEEP guided by G5 ventilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ARDS patients Transferred from FEMH emergency room or Ward into the medical intensive care unit. Patients with invasive mechanical ventilation Patient, agent or consent of families learn about and subjects were willing to sign the consent form. Exclusion Criteria: burning electric knife used pacemaker used Large area wound is used gauze to cover Wound or burn injuries of the chest wall. Patients included conditions are not met.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EIT<br>PEEP titration is performed where EIT is measured at the same time. After PEEP titration, EIT data is analyzed. Global inhomogeneity index and regional compliance based on EIT are calculated. PEEP level is selected when ventilation distribution is most homogeneous. | Device: optimal PEEP guided by EIT<br>* Patients are randomly assigned to EIT group or G5 group. PEEP selected in EIT group is based on GI index and regional compliance. PEEP decided in G5 group is based on the ventilator.<br>|
| Experimental: G5 VENTILATOR<br>Protective Ventilation Tool by G5(MV) to determine the optimal PEEP on ARDS patients. The results are delivered by the ventilator automatically. | Device: optimal PEEP guided by G5 ventilator<br>* Patients are randomly assigned to EIT group or G5 group. PEEP selected in EIT group is based on GI index and regional compliance. PEEP decided in G5 group is based on the ventilator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory system parameter | Compliance | 48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MV day | Number of days with ventilator and ICU stay | 64 days | 
| Respiratory system parameter | PaO2/FiO2 | 48 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optimal positive end-expiratory pressure determination, Electrical impedance tomography