NCT03112512

Brief Summary

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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

April 20, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

March 15, 2017

Last Update Submit

September 2, 2020

Conditions

Acute Respiratory Distress Syndrome

Keywords

optimal positive end-expiratory pressure determinationElectrical impedance tomography

Outcome Measures

Primary Outcomes (1)

  • Respiratory system parameter

    Compliance

    48 hrs

Secondary Outcomes (2)

  • MV day

    64 days

  • Respiratory system parameter

    48 hrs

Study Arms (2)

EIT

EXPERIMENTAL

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

G5 VENTILATOR

EXPERIMENTAL

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

Interventions

optimal PEEP guided by EITDEVICE

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.

EIT
optimal PEEP guided by G5 ventilatorDEVICE

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

Eligibility Criteria

Age20 Years - 90 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details20-90 years old
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Electrical impedance tomography (EIT)

New Taipei City, No.21, Sec. 2, Nanya S. Rd., Banciao Dist, 220, Taiwan

Location

Related Publications (4)

  • 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.

    PMID: 28103448RESULT

  • 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.

    PMID: 33361553DERIVED

  • 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.

    PMID: 31587120DERIVED

  • 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.

    PMID: 30656479DERIVED

Related Links

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Chang MEI YUN, MASTER

    FEMH -chest division

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2017

First Posted

April 13, 2017

Study Start

April 20, 2017

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

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

Locations

TW(1)