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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03112512
• Other study ID #: FEMH-105117-E
• Status: Completed
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: September 2020
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To Select the Optimal Positive End-expiratory Pressure in Moderate and Severe Acute Respiratory Distress Syndrome Patients by Using:

1. the novel Non-invasive Electrical Impedance Tomography Guided Method

2. the Protective ventilation tool G5(MV)

Description:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

1. ARDS patients

2. Transferred from FEMH emergency room or Ward into the medical intensive care unit.

3. Patients with invasive mechanical ventilation

4. Patient, agent or consent of families learn about and subjects were willing to sign the consent form.

Exclusion Criteria:

1. burning electric knife used

2. pacemaker used

3. Large area wound is used gauze to cover

4. Wound or burn injuries of the chest wall.

5. Patients included conditions are not met.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• optimal PEEP guided by EIT
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.
• optimal PEEP guided by G5 ventilator
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.

Locations

Country	Name	City	State
Taiwan	Electrical impedance tomography (EIT)	New Taipei City	No.21, Sec. 2, Nanya S. Rd., Banciao Dist

Sponsors (1)

Lead Sponsor	Collaborator
Mei-Yun Chang

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Franchineau G, Bréchot N, Lebreton G, Hekimian G, Nieszkowska A, Trouillet JL, Leprince P, Chastre J, Luyt CE, Combes A, Schmidt M. Bedside Contribution of Electrical Impedance Tomography to Setting Positive End-Expiratory Pressure for Extracorporeal Memb — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory system parameter	Compliance	48 hrs
Secondary	MV day	Number of days with ventilator and ICU stay	64 days
Secondary	Respiratory system parameter	PaO2/FiO2	48 hrs

External Links

•   Bedside Contribution of Electrical Impedance Tomography to Set Positive End-Expiratory Pressure for ECMO-Treated Severe ARDS Patients.