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

Primary Purpose

Acute Respiratory Distress Syndrome

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

optimal PEEP guided by EIT

optimal PEEP guided by G5 ventilator

About this trial

This is an interventional supportive care trial for Acute Respiratory Distress Syndrome focused on measuring optimal positive end-expiratory pressure determination, Electrical impedance tomography

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Electrical impedance tomography (EIT)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

EIT

G5 VENTILATOR

Arm Description

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.

Protective Ventilation Tool by G5(MV) to determine the optimal PEEP on ARDS patients. The results are delivered by the ventilator automatically.

Outcomes

Primary Outcome Measures

Respiratory system parameter

Compliance

Secondary Outcome Measures

MV day

Number of days with ventilator and ICU stay

Respiratory system parameter

PaO2/FiO2

Full Information

NCT ID

NCT03112512

First Posted

March 15, 2017

Last Updated

September 2, 2020

Sponsor

Mei-Yun Chang

1. Study Identification

Unique Protocol Identification Number

NCT03112512

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

April 20, 2017 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mei-Yun Chang

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Distress Syndrome

Keywords

optimal positive end-expiratory pressure determination, Electrical impedance tomography

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EIT

Arm Type

Experimental

Arm Description

Arm Title

G5 VENTILATOR

Arm Type

Experimental

Arm Description

Protective Ventilation Tool by G5(MV) to determine the optimal PEEP on ARDS patients. The results are delivered by the ventilator automatically.

Intervention Type

Device

Intervention Name(s)

optimal PEEP guided by EIT

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

optimal PEEP guided by G5 ventilator

Intervention Description

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.

Primary Outcome Measure Information:

Title

Respiratory system parameter

Description

Compliance

Time Frame

48 hrs

Secondary Outcome Measure Information:

Title

MV day

Description

Number of days with ventilator and ICU stay

Time Frame

64 days

Title

Respiratory system parameter

Description

PaO2/FiO2

Time Frame

48 hrs

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

20-90 years old

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chang MEI YUN, MASTER

Organizational Affiliation

FEMH -chest division

Official's Role

Principal Investigator

Facility Information:

Facility Name

Electrical impedance tomography (EIT)

City

New Taipei City

State/Province

No.21, Sec. 2, Nanya S. Rd., Banciao Dist

ZIP/Postal Code

220

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

no sharing plan, including what IPD are to be shared with other researchers

Citations:

PubMed Identifier

28103448

Citation

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.

Results Reference

result

PubMed Identifier

33361553

Citation

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.

Results Reference

derived

PubMed Identifier

31587120

Citation

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.

Results Reference

derived

PubMed Identifier

30656479

Citation

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.

Results Reference

derived

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/28103448

Description

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

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

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