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

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ClinicalTrials.gov Identifier: NCT03112512
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mei-Yun Chang, Far Eastern Memorial Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 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 : April 20, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018


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.




Primary Outcome Measures :
  1. respiratory parameter [ Time Frame: 3 days ]
    arterial partial pressure of oxygen


Secondary Outcome Measures :
  1. ICU stay [ Time Frame: 64 days ]
    number of days with ventilator and ICU stay

  2. weaning successful rate [ Time Frame: 64 days ]
    weaning successfulness at day 64 after first mechanical ventilation



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   20-90 years old
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112512


Contacts
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Contact: Chang Mei Yun, master 8862-89667000 ext 1854 changmy30@yahoo.com.tw
Contact: Chang hou tai, PHD 8862-89667000 ext 4532 houtai38@gmail.com

Locations
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Taiwan
Electrical impedance tomography (EIT) Recruiting
New Taipei City, No.21, Sec. 2, Nanya S. Rd., Banciao Dist, Taiwan, 220
Contact: Chang Mei Yun, master    8862-89667000 ext 1854    changmy30@yahoo.com.tw   
Sponsors and Collaborators
Mei-Yun Chang
Investigators
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Principal Investigator: Chang MEI YUN, MASTER FEMH -chest division

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mei-Yun Chang, Principal Investigator, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT03112512     History of Changes
Other Study ID Numbers: FEMH-105117-E
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no sharing plan, including what IPD are to be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mei-Yun Chang, Far Eastern Memorial Hospital:
optimal positive end-expiratory pressure determination
Electrical impedance tomography
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury