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

NCT ID: NCT03112512

Last Updated: 2020-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2019-02-28

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:

1. the novel Non-invasive Electrical Impedance Tomography Guided Method
2. the Protective ventilation tool G5(MV)

Detailed Description

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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.

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

optimal PEEP guided by EIT

Intervention Type DEVICE

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.

G5 VENTILATOR

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

Group Type EXPERIMENTAL

optimal PEEP guided by G5 ventilator

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mei-Yun Chang

OTHER

Sponsor Role lead

Responsible Party

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Mei-Yun Chang

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chang MEI YUN, MASTER

Role: PRINCIPAL_INVESTIGATOR

FEMH -chest division

Locations

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Electrical impedance tomography (EIT)

New Taipei City, No.21, Sec. 2, Nanya S. Rd., Banciao Dist, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 28103448 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33361553 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31587120 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30656479 (View on PubMed)

Related Links

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

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

Other Identifiers

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FEMH-105117-E

Identifier Type: -

Identifier Source: org_study_id

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