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Completed

NCT Number: NCT03112512

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

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)

Completed

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Key information

Conditions

Acute Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Electrical impedance tomography (EIT)

New Taipei City, No.21, Sec. 2, Nanya S. Rd., Banciao Dist, 220, Taiwan

About this study

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

optimal PEEP guided by EIT

Device

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.

optimal PEEP guided by G5 ventilator

Device

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.

Primary outcomes

  1. Respiratory system parameter

    Time frame: 48 hrs

    Compliance

Secondary outcomes

  1. MV day

    Time frame: 64 days

    Number of days with ventilator and ICU stay

  2. Respiratory system parameter

    Time frame: 48 hrs

    PaO2/FiO2

Sponsors and collaborators

Lead sponsor

Mei-Yun Chang

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2017
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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