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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 : Not yet recruiting
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Robert C. Hyzy, MD, University of Michigan

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).

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome ARDS Other: Usual care Device: PEEP titration by EIT Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
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
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

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.
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




Primary Outcome Measures :
  1. Percent change in lung inflammation as measured by the biomarker Interleukin 6 (IL-6) [ Time Frame: Up to 24 hours ]
  2. Lung inflammation as measured by the biomarker Interleukin 6 (IL-6) [ Time Frame: Up to 24 hours ]
  3. Percent change in lung inflammation as measured by the biomarker Interleukin 8 (IL-8) [ Time Frame: Up to 24 hours ]
  4. Lung inflammation as measured by the biomarker Interleukin 8 (IL-8) [ Time Frame: Up to 24 hours ]
  5. Percent change in lung inflammation as measured by the biomarker tumor necrosis factor receptor 1 (TNFR1) [ Time Frame: Up to 24 hours ]
  6. Lung inflammation as measured by the biomarker tumor necrosis factor receptor 1 (TNFR1) [ Time Frame: Up to 24 hours ]
  7. 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 ]
  8. Lung inflammation as measured by the biomarker soluble form of receptor for advanced glycation end products (sRAGE) [ Time Frame: Up to 24 hours ]
  9. Percent change in lung inflammation as measured by the biomarker surfactant protein D (SP-D) [ Time Frame: Up to 24 hours ]
  10. Lung inflammation as measured by the biomarker surfactant protein D (SP-D) [ Time Frame: Up to 24 hours ]
  11. Percent change in lung inflammation as measured by the biomarker angiopoietin-2 [ Time Frame: Up to 24 hours ]
  12. Lung inflammation as measured by the biomarker angiopoietin-2 [ Time Frame: Up to 24 hours ]
  13. Percent change in lung inflammation as measured by the biomarker Von Willebrand Factor (VWF) [ Time Frame: Up to 24 hours ]
  14. Lung inflammation as measured by the biomarker Von Willebrand Factor (VWF) [ Time Frame: Up to 24 hours ]

Secondary Outcome Measures :
  1. Percent change in lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen (PaO2) [ Time Frame: Up to 24 hours ]
  2. Lung inflammation as measured by physiologic parameter: Partial pressure of arterial oxygen (PaO2) [ Time Frame: Up to 24 hours ]
  3. 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 ]
  4. 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 ]
  5. Percent change in lung inflammation as measured by physiologic parameter: Plateau pressure [ Time Frame: Up to 24 hours ]
  6. Lung inflammation as measured by physiologic parameter: Plateau pressure [ Time Frame: Up to 24 hours ]
  7. Percent change in lung inflammation as measured by physiologic parameter: Driving Pressure [ Time Frame: Up to 24 hours ]
  8. Lung inflammation as measured by physiologic parameter: Driving Pressure [ Time Frame: Up to 24 hours ]
  9. Percent change in lung inflammation as measured by physiologic parameter: Static compliance [ Time Frame: Up to 24 hours ]
  10. Lung inflammation as measured by physiologic parameter: Static compliance [ Time Frame: Up to 24 hours ]
  11. Percent change in lung inflammation as measured by physiologic parameter: Dynamic compliance [ Time Frame: Up to 24 hours ]
  12. Lung inflammation as measured by physiologic parameter: Dynamic compliance [ Time Frame: Up to 24 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03793842


Contacts
Contact: Kristine Nelson 734-232-4285 flygrrl@umich.edu

Locations
United States, Michigan
The University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kristine Nelson    734-232-4285    flygrrl@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Robert Hyzy, MD University of Michigan

Responsible Party: Robert C. Hyzy, MD, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03793842     History of Changes
Other Study ID Numbers: HUM00148126
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Robert C. Hyzy, MD, University of Michigan:
Electrical Impedance Tomography
Ventilator
Lung
Respiration

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury