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

NCT ID: NCT03498807

Last Updated: 2019-10-22

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

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-13

Study Completion Date

2019-02-28

Brief Summary

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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

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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.

Conditions

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ARDS Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU.(P/F≦200+PEEP≧ 5cmH20)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
During this period, all patients were total sedation using continuous infusion, to prevent any spontaneous breathing .All patients were ventilated using a ventilator

Study Groups

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Control group_Use Ventilator P/V tool

Use the Pressure/Volume Loop

Group Type EXPERIMENTAL

Ventiltor P/V Loop

Intervention Type DEVICE

determine the Optimal PEEP and keep 48hr on ARDS patients

Study group_Use EIT

Use the Electrical Impedance Tomography

Group Type ACTIVE_COMPARATOR

Electrical Impedance Tomography

Intervention Type DEVICE

determine Optimal PEEP and keep 48hr on ARDS patients

Interventions

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Ventiltor P/V Loop

determine the Optimal PEEP and keep 48hr on ARDS patients

Intervention Type DEVICE

Electrical Impedance Tomography

determine Optimal PEEP and keep 48hr on ARDS patients

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hui-Ju Hsu

OTHER

Sponsor Role lead

Responsible Party

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Hui-Ju Hsu

respiratory therapist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hou T Chang, doctor

Role: STUDY_DIRECTOR

Far Eastern Memorial Hospital

Ping H Wang, Bachelor

Role: STUDY_DIRECTOR

Far Eastern Memorial Hospital

Locations

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Far Eastern Memorial Hospital

Taipei County, Banqiao Dist, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 25399892 (View on PubMed)

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.

Reference Type RESULT
PMID: 23362167 (View on PubMed)

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.

Reference Type RESULT
PMID: 28973075 (View on PubMed)

Other Identifiers

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106094-E

Identifier Type: -

Identifier Source: org_study_id

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