A Comparison of Optimal PEEP Determination Guided by EIT... | NCT03498807

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

NCT03498807

Sponsor

Hui-Ju Hsu

Status

Completed

Last Update Posted

Oct 22, 2019Actual

Enrollment

87Actual

Phase

Not Applicable

Conditions

ARDS
Acute Respiratory Distress Syndrome

Interventions

Ventiltor P/V Loop
Electrical Impedance Tomography

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 13, 2017Actual

Primary Completion Date

Feb 28, 2019Actual

Completion Date

Feb 28, 2019Actual

First Submitted Date

Apr 5, 2018

First Submission Date that Met QC Criteria

Apr 13, 2018

First Posted Date

Apr 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2019

Last Update Posted Date

Oct 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group_Use Ventilator P/V tool	Experimental	Use the Pressure/Volume Loop	Device: Ventiltor P/V Loop
Study group_Use EIT	Active Comparator	Use the Electrical Impedance Tomography	Device: Electrical Impedance Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ventiltor P/V Loop	Device	determine the Optimal PEEP and keep 48hr on ARDS patients	Control group_Use Ventilator P/V tool

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare the survival rate between two groups	Calculate the survival rate	Compare the survival rate between two groups during 91 days in hospitalization

Secondary Outcomes

Measure	Description	Time Frame
Oxygention improve rate in the hospital	Calculate PaO2/FiO2 ratio improvement rate in the hospital	Compare the PaO2/FiO2 ratio after fixed Optimal PEEP 48hrs later

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hou T Chang, doctor	Far Eastern Memorial Hospital	Study Director
Ping H Wang, Bachelor	Far Eastern Memorial Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		Taipei County	Banqiao Dist	22060	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25399892	Result	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.
23362167

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders