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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03498807
Enrollment
87
Registered
2018-04-17
Start date
2017-04-13
Completion date
2019-02-28
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, ARDS

Keywords

ARDS, Acute Respiratory Distress Syndrome, PEEP, pressure-volume loop, Positive End-Expiratory Pressure, hysteresis

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.

Interventions

DEVICEVentiltor P/V Loop

determine the Optimal PEEP and keep 48hr on ARDS patients

DEVICEElectrical Impedance Tomography

determine Optimal PEEP and keep 48hr on ARDS patients

Sponsors

Hui-Ju Hsu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compare the survival rate between two groupsCompare the survival rate between two groups during 91 days in hospitalizationCalculate the survival rate

Secondary

MeasureTime frameDescription
Oxygention improve rate in the hospitalCompare the PaO2/FiO2 ratio after fixed Optimal PEEP 48hrs laterCalculate PaO2/FiO2 ratio improvement rate in the hospital

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026