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

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

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)

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: optimal PEEP guided by EIT; Device: optimal PEEP guided by G5 ventilator

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • No.21, Sec. 2, Nanya S. Rd., Banciao Dist
    • New Taipei City, No.21, Sec. 2, Nanya S. Rd., Banciao Dist, Taiwan, 220
      • Electrical impedance tomography (EIT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EIT; 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; 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.
Experimental: G5 VENTILATOR; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mei-Yun Chang
• Investigators: Principal Investigator: Chang MEI YUN, MASTER, FEMH -chest division

Publications and helpful links

General Publications

• Franchineau G, Brechot 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 Membrane Oxygenation-treated Patients with Severe Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2017 Aug 15;196(4):447-457. doi: 10.1164/rccm.201605-1055OC.
• Hsu HJ, Chang HT, Zhao Z, Wang PH, Zhang JH, Chen YS, Frerichs I, Moller K, Fu F, Hsu HS, Chuang SP, Hsia HY, Yen DH. Positive end-expiratory pressure titration with electrical impedance tomography and pressure-volume curve: a randomized trial in moderate to severe ARDS. Physiol Meas. 2021 Feb 6;42(1):014002. doi: 10.1088/1361-6579/abd679.
• Zhao Z, Lee LC, Chang MY, Frerichs I, Chang HT, Gow CH, Hsu YL, Moller K. The incidence and interpretation of large differences in EIT-based measures for PEEP titration in ARDS patients. J Clin Monit Comput. 2020 Oct;34(5):1005-1013. doi: 10.1007/s10877-019-00396-8. Epub 2019 Oct 5.
• Zhao Z, Chang MY, Chang MY, Gow CH, Zhang JH, Hsu YL, Frerichs I, Chang HT, Moller K. Positive end-expiratory pressure titration with electrical impedance tomography and pressure-volume curve in severe acute respiratory distress syndrome. Ann Intensive Care. 2019 Jan 17;9(1):7. doi: 10.1186/s13613-019-0484-0.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: April 8, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Electrical impedance tomography; optimal positive end-expiratory pressure determination
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: FEMH-105117-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: no sharing plan, including what IPD are to be shared with other researchers

Drug and device information, study documents

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