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A Comparison of Optimal PEEP Determination Guided by EIT and Conventional Protective Ventilation Tool in ARDS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498807
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Hui-Ju Hsu, Far Eastern Memorial Hospital

Brief Summary:

The study of positive end-expiratory pressure(PEEP) in the setting mode has not yet been conclusive. there are several ways to choose the best positive end-expiratory pressure(PEEP) mode for ARDS patients. In this study ,the investigators selected two best positive end-expiratory pressure(PEEP) assessment methods to compare:

First is using the conventional postive ventilator to choose positive end-expiratory pressure(PEEP) and the new non-invasive electrical impedance tomography(EIT) guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, we utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support at a medical center medical ICU (MICU) and cardiovascular ICU (CVICU)- the Far Eastern memorial hospital, Taiwan.


Condition or disease Intervention/treatment Phase
ARDS Acute Respiratory Distress Syndrome Device: Ventiltor P/V Loop Device: Electrical Impedance Tomography Not Applicable

Detailed Description:

Acute respiratory distress syndrome (ARDS),over the years in the treatment policy has been confirmed that: with low tidal volume to achieve lung protection strategy and high positive end-expiratory pressure (PEEP), both can effectively reduce the mortality rate. And increase PEEP,the alveolar pressure is greater than the atmospheric pressure when exhaled,So that can be effective expansion of the lungs to avoid spitting at the end of the alveolar collapse.

The study of PEEP in the setting mode has not yet been conclusive. Currently in the clinical situation,there are several ways to choose the best PEEP mode for ARDS patients. In this study the investigators selected two best PEEP assessment methods to compare:

First is using the conventional postive ventilator to choose optimal and the new non-invasive electrical impedance tomography guided method and evaluation the treatment outcome in moderate and severe acute respiratory distress syndrome patients by using pressure-volume curve guided and electrical impedance tomography guided positive end-expiratory pressure setting. In this project, the investigators utilize a newly available non-invasive method- electric impedance tomography (EIT) and Protective Ventilation to determine the optimal PEEP on ARDS patients required invasive mechanical ventilator support in ICU at the Far Eastern memorial hospital, Taiwan.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU.(P/F≦200+PEEP≧ 5cmH20)
Masking: Single (Participant)
Masking Description: During this period, all patients were total sedation using continuous infusion, to prevent any spontaneous breathing .All patients were ventilated using a ventilator
Primary Purpose: Treatment
Official Title: A Comparison of Optimal Positive End Expiratory Pressure Determination Guided by Electrical Impedance Tomography and Conventional Protective Ventilation Tool in Acute Respiratory Distress Syndrome Patients
Actual Study Start Date : April 13, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019


Arm Intervention/treatment
Experimental: Control group_Use Ventilator P/V tool
Use the Pressure/Volume Loop
Device: Ventiltor P/V Loop
determine the Optimal PEEP and keep 48hr on ARDS patients

Active Comparator: Study group_Use EIT
Use the Electrical Impedance Tomography
Device: Electrical Impedance Tomography
determine Optimal PEEP and keep 48hr on ARDS patients




Primary Outcome Measures :
  1. Compare the survival rate between two groups [ Time Frame: Compare the survival rate between two groups during 91 days in hospitalization ]
    Calculate the survival rate


Secondary Outcome Measures :
  1. Oxygention improve rate in the hospital [ Time Frame: Compare the PaO2/FiO2 ratio after fixed Optimal PEEP 48hrs later ]
    Calculate PaO2/FiO2 ratio improvement rate in the hospital



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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe ARDS patient on mechanical ventilation from ER or word transfer ICU. (P/F≦ 200 with PEEP ≥ 5cmH20) (PEEP greater than or equal to 5 cm H2O and Berlin criteria for ARDS)

Exclusion Criteria:

  • On pacemaker
  • Pregnant
  • Thoracic or spinal cord trauma
  • Pneumothorax
  • Hemodynamic instability
  • IICP

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): NCT03498807


Locations
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Taiwan
Far Eastern Memorial Hospital
Taipei county, Banqiao Dist, Taiwan, 22060
Sponsors and Collaborators
Hui-Ju Hsu
Investigators
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Study Director: Hou T Chang, doctor Far Eastern Memorial Hospital
Study Director: Ping H Wang, Bachelor Far Eastern Memorial Hospital

Publications of Results:
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Responsible Party: Hui-Ju Hsu, respiratory therapist, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT03498807    
Other Study ID Numbers: 106094-E
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Still in the research phase.May be consider later

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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 Hui-Ju Hsu, Far Eastern Memorial Hospital:
ARDS
Acute Respiratory Distress Syndrome
PEEP
pressure-volume loop
Positive End-Expiratory Pressure
hysteresis
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury