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

• Sponsor: Mei-Yun Chang (Other)
• Overall Status: Completed
• CT.gov ID: NCT03112512
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome	Device: optimal PEEP guided by EIT; Device: optimal PEEP guided by G5 ventilator	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official 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
• Actual Study Start Date: Apr 20, 2017
• Actual Primary Completion Date: Feb 28, 2019
• Actual Study Completion Date: Feb 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: optimal 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.
Experimental: G5 VENTILATOR Protective Ventilation Tool by G5(MV) to determine the optimal PEEP on ARDS patients. The results are delivered by the ventilator automatically.	Device: optimal 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.

Outcome Measures

Primary Outcome Measures

1. Respiratory system parameter [48 hrs]

   Compliance

Secondary Outcome Measures

1. MV day [64 days]

   Number of days with ventilator and ICU stay

2. Respiratory system parameter [48 hrs]

   PaO2/FiO2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Electrical impedance tomography (EIT)	New Taipei City	No.21, Sec. 2, Nanya S. Rd., Banciao Dist	Taiwan	220

Sponsors and Collaborators

• Mei-Yun Chang

Investigators

• Principal Investigator: Chang MEI YUN, MASTER, FEMH -chest division

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Bedside Contribution of Electrical Impedance Tomography to Set Positive End-Expiratory Pressure for ECMO-Treated Severe ARDS Patients.

Publications

None provided.

• Responsible Party: Mei-Yun Chang, Principal Investigator, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03112512
• Other Study ID Numbers: FEMH-105117-E
• First Posted: Apr 13, 2017
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mei-Yun Chang, Principal Investigator, Far Eastern Memorial Hospital: optimal positive end-expiratory pressure determination; Electrical impedance tomography
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome

Study Results

No Results Posted as of Sep 4, 2020