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Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome

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ClinicalTrials.gov Identifier: NCT03793842
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Robert C. Hyzy, MD, University of Michigan

Tracking Information
First Submitted Date  ICMJE January 3, 2019
First Posted Date  ICMJE January 4, 2019
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE March 4, 2019
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
  • Percent change in lung inflammation as measured by the biomarker Interleukin 6 (IL-6) [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by the biomarker Interleukin 6 (IL-6) [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by the biomarker Interleukin 8 (IL-8) [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by the biomarker Interleukin 8 (IL-8) [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by the biomarker tumor necrosis factor receptor 1 (TNFR1) [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by the biomarker tumor necrosis factor receptor 1 (TNFR1) [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by the biomarker soluble form of receptor for advanced glycation end products (sRAGE) [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by the biomarker soluble form of receptor for advanced glycation end products (sRAGE) [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by the biomarker surfactant protein D (SP-D) [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by the biomarker surfactant protein D (SP-D) [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by the biomarker angiopoietin-2 [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by the biomarker angiopoietin-2 [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by the biomarker Von Willebrand Factor (VWF) [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by the biomarker Von Willebrand Factor (VWF) [ Time Frame: Up to 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03793842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
  • Percent change in lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen (PaO2) [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen (PaO2) [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen/Fraction of Inspired Oxygen (P/F ratio) [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen/Fraction of Inspired Oxygen (P/F ratio) [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by physiologic parameter: Plateau pressure [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by physiologic parameter: Plateau pressure [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by physiologic parameter: Driving Pressure [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by physiologic parameter: Driving Pressure [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by physiologic parameter: Static compliance [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by physiologic parameter: Static compliance [ Time Frame: Up to 24 hours ]
  • Percent change in lung inflammation as measured by physiologic parameter: Dynamic compliance [ Time Frame: Up to 24 hours ]
  • Lung inflammation as measured by physiologic parameter: Dynamic compliance [ Time Frame: Up to 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome
Official Title  ICMJE Use of Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome
Brief Summary Doctors follow a standard ventilator management strategy when making adjustments to the breathing machine to optimize the amount of oxygen into the lungs. The purpose of this study is to assess whether the EIT (electrical impedance tomography) device can be an additional useful tool for ventilator management and identifying the ideal positive end-expiratory pressure (PEEP).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • ARDS
Intervention  ICMJE
  • Other: Usual care
    Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.
  • Device: PEEP titration by EIT
    PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).
    Other Name: Drager PulmoVista 500 EIT System
Study Arms  ICMJE
  • Experimental: Usual care then PEEP titration by EIT
    Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan ARDS protocol high-PEEP arm
    Interventions:
    • Other: Usual care
    • Device: PEEP titration by EIT
  • Experimental: PEEP titration by EIT then usual care
    Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.
    Interventions:
    • Other: Usual care
    • Device: PEEP titration by EIT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Endotracheal ventilation for < 1 week (168 hours)
  • Presence of all of the following conditions for < 48 hours i. PaO2/FiO2 < 150 with PEEP > 5 cm H2O for > 30 min. ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload
  • All criteria listed in (3) developed within 1 week of a known clinical insult or new or worsening respiratory symptoms

Exclusion Criteria:

  • Lack of informed consent
  • Known pregnancy
  • ECMO
  • Severe chronic respiratory disease requiring home oxygen therapy or ventilation
  • Calculated BMI of greater than 50
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristine Nelson 734-232-4285 flygrrl@umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03793842
Other Study ID Numbers  ICMJE HUM00148126
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert C. Hyzy, MD, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Hyzy, MD University of Michigan
PRS Account University of Michigan
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP