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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Device: optimal PEEP guided by G5 ventilator; Device: optimal PEEP guided by EIT

• Registration Number: NCT03112512
• Lead Sponsor: Mei-Yun Chang

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.

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-04-08
• Study First Posted: 2017-04-13
• Study Start: 2017-04-20
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-02
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G5 VENTILATOR	optimal PEEP guided by G5 ventilator	Protective Ventilation Tool by G5(MV) to determine the optimal PEEP on ARDS patients. The results are delivered by the ventilator automatically.
EIT	optimal PEEP guided by EIT	PEEP titration is performed where EIT is measured at the same time. After PEEP titration, EIT data is analyzed. Global inhomogeneity index and regional compliance based on EIT are calculated. PEEP level is selected when ventilation distribution is most homogeneous.

Primary Outcome Measures

Name	Time	Method
Respiratory system parameter	48 hrs	Compliance

Secondary Outcome Measures

Name	Time	Method
Respiratory system parameter	48 hrs	PaO2/FiO2
MV day	64 days	Number of days with ventilator and ICU stay

Trial Locations

Locations (1)

Electrical impedance tomography (EIT); 🇨🇳 New Taipei City, No.21, Sec. 2, Nanya S. Rd., Banciao Dist, Taiwan