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A Comparison of Optimal PEEP Determination Guided by EIT and Conventional Protective Ventilation Tool in ARDS Patients

Primary Purpose

ARDS, Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ventiltor P/V Loop
Electrical Impedance Tomography
Sponsored by
Hui-Ju Hsu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS focused on measuring ARDS, Acute Respiratory Distress Syndrome, PEEP, pressure-volume loop, Positive End-Expiratory Pressure, hysteresis

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU. (P/F≦ 200 with PEEP ≥ 5cmH20) (PEEP greater than or equal to 5 cm H2O and Berlin criteria for ARDS)

Exclusion Criteria:

  • On pacemaker
  • Pregnant
  • Thoracic or spinal cord trauma
  • Pneumothorax
  • Hemodynamic instability
  • IICP

Sites / Locations

  • Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control group_Use Ventilator P/V tool

Study group_Use EIT

Arm Description

Use the Pressure/Volume Loop

Use the Electrical Impedance Tomography

Outcomes

Primary Outcome Measures

Compare the survival rate between two groups
Calculate the survival rate

Secondary Outcome Measures

Oxygention improve rate in the hospital
Calculate PaO2/FiO2 ratio improvement rate in the hospital

Full Information

First Posted
April 5, 2018
Last Updated
October 18, 2019
Sponsor
Hui-Ju Hsu
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1. Study Identification

Unique Protocol Identification Number
NCT03498807
Brief Title
A Comparison of Optimal PEEP Determination Guided by EIT and Conventional Protective Ventilation Tool in ARDS Patients
Official Title
A Comparison of Optimal Positive End Expiratory Pressure Determination Guided by Electrical Impedance Tomography and Conventional Protective Ventilation Tool in Acute Respiratory Distress Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 13, 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
Hui-Ju Hsu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study of positive end-expiratory pressure(PEEP) in the setting mode has not yet been conclusive. there are several ways to choose the best positive end-expiratory pressure(PEEP) mode for ARDS patients. In this study ,the investigators selected two best positive end-expiratory pressure(PEEP) assessment methods to compare: First is using the conventional postive ventilator to choose positive end-expiratory pressure(PEEP) and the new non-invasive electrical impedance tomography(EIT) guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, we utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support at a medical center medical ICU (MICU) and cardiovascular ICU (CVICU)- the Far Eastern memorial hospital, Taiwan.
Detailed Description
Acute respiratory distress syndrome (ARDS),over the years in the treatment policy has been confirmed that: with low tidal volume to achieve lung protection strategy and high positive end-expiratory pressure (PEEP), both can effectively reduce the mortality rate. And increase PEEP,the alveolar pressure is greater than the atmospheric pressure when exhaled,So that can be effective expansion of the lungs to avoid spitting at the end of the alveolar collapse. The study of PEEP in the setting mode has not yet been conclusive. Currently in the clinical situation,there are several ways to choose the best PEEP mode for ARDS patients. In this study the investigators selected two best PEEP assessment methods to compare: First is using the conventional postive ventilator to choose optimal and the new non-invasive electrical impedance tomography guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, the investigators utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support in ICU at the Far Eastern memorial hospital, Taiwan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Acute Respiratory Distress Syndrome
Keywords
ARDS, Acute Respiratory Distress Syndrome, PEEP, pressure-volume loop, Positive End-Expiratory Pressure, hysteresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU.(P/F≦200+PEEP≧ 5cmH20)
Masking
Participant
Masking Description
During this period, all patients were total sedation using continuous infusion, to prevent any spontaneous breathing .All patients were ventilated using a ventilator
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group_Use Ventilator P/V tool
Arm Type
Experimental
Arm Description
Use the Pressure/Volume Loop
Arm Title
Study group_Use EIT
Arm Type
Active Comparator
Arm Description
Use the Electrical Impedance Tomography
Intervention Type
Device
Intervention Name(s)
Ventiltor P/V Loop
Intervention Description
determine the Optimal PEEP and keep 48hr on ARDS patients
Intervention Type
Device
Intervention Name(s)
Electrical Impedance Tomography
Intervention Description
determine Optimal PEEP and keep 48hr on ARDS patients
Primary Outcome Measure Information:
Title
Compare the survival rate between two groups
Description
Calculate the survival rate
Time Frame
Compare the survival rate between two groups during 91 days in hospitalization
Secondary Outcome Measure Information:
Title
Oxygention improve rate in the hospital
Description
Calculate PaO2/FiO2 ratio improvement rate in the hospital
Time Frame
Compare the PaO2/FiO2 ratio after fixed Optimal PEEP 48hrs later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU. (P/F≦ 200 with PEEP ≥ 5cmH20) (PEEP greater than or equal to 5 cm H2O and Berlin criteria for ARDS) Exclusion Criteria: On pacemaker Pregnant Thoracic or spinal cord trauma Pneumothorax Hemodynamic instability IICP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hou T Chang, doctor
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ping H Wang, Bachelor
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei county
State/Province
Banqiao Dist
ZIP/Postal Code
22060
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Still in the research phase.May be consider later
Citations:
PubMed Identifier
25399892
Citation
Xu L, Wang Z, Li T, Li Z, Hu X, Feng Q, Duan D, Gao X. [Comparison of extracorporeal membrane oxygenation and mechanical ventilation for inter-hospital transport of severe acute respiratory distress syndrome patients]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2014 Nov;26(11):789-93. doi: 10.3760/cma.j.issn.2095-4352.2014.11.005. Chinese.
Results Reference
result
PubMed Identifier
23362167
Citation
Pintado MC, de Pablo R, Trascasa M, Milicua JM, Rogero S, Daguerre M, Cambronero JA, Arribas I, Sanchez-Garcia M. Individualized PEEP setting in subjects with ARDS: a randomized controlled pilot study. Respir Care. 2013 Sep;58(9):1416-23. doi: 10.4187/respcare.02068. Epub 2013 Jan 29.
Results Reference
result
PubMed Identifier
28973075
Citation
Sahetya SK, Brower RG. Lung Recruitment and Titrated PEEP in Moderate to Severe ARDS: Is the Door Closing on the Open Lung? JAMA. 2017 Oct 10;318(14):1327-1329. doi: 10.1001/jama.2017.13695. No abstract available.
Results Reference
result

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A Comparison of Optimal PEEP Determination Guided by EIT and Conventional Protective Ventilation Tool in ARDS Patients

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