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A Comparison of Optimal PEEP Determination Guided by EIT and G5 Device in Moderate and Severe ARDS Patients

A Comparison of Optimal Positive End-expiratory Pressure Determination Guided by Electrical Impedance Tomography and Protective Ventilation Tool by G5(MV) in Moderate and Severe Acute Respiratory Distress Syndrome Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03112512
Enrollment
88
Registered
2017-04-13
Start date
2017-04-20
Completion date
2019-02-28
Last updated
2020-09-04

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

Conditions

Acute Respiratory Distress Syndrome

Keywords

optimal positive end-expiratory pressure determination, Electrical impedance tomography

Brief summary

To Select the Optimal Positive End-expiratory Pressure in Moderate and Severe Acute Respiratory Distress Syndrome Patients by Using: 1. the novel Non-invasive Electrical Impedance Tomography Guided Method 2. the Protective ventilation tool G5(MV)

Detailed description

1. To titrate PEEP guided by EIT. A global inhomogeneity (GI) index and regional compliance based on EIT were developed to quantify the tidal volume distribution within the lung. The aim of this study was to test the feasibility of optimizing PEEP with respect to ventilation homogeneity using the GI index and regional compliance. 2. To titrate PEEP with the Protective Ventilation Tool by G5(MV). The new generation of ventilator will deliver an optimal PEEP on ARDS patients based on their status automatically.

Interventions

DEVICEoptimal PEEP guided by EIT

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.

DEVICEoptimal PEEP guided by G5 ventilator

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.

Sponsors

Mei-Yun Chang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. ARDS patients 2. Transferred from FEMH emergency room or Ward into the medical intensive care unit. 3. Patients with invasive mechanical ventilation 4. Patient, agent or consent of families learn about and subjects were willing to sign the consent form.

Exclusion criteria

1. burning electric knife used 2. pacemaker used 3. Large area wound is used gauze to cover 4. Wound or burn injuries of the chest wall. 5. Patients included conditions are not met.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory system parameter48 hrsCompliance

Secondary

MeasureTime frameDescription
MV day64 daysNumber of days with ventilator and ICU stay
Respiratory system parameter48 hrsPaO2/FiO2

Countries

Taiwan

Outcome results

None listed

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