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

Primary Purpose

Acute Respiratory Distress Syndrome, ARDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual care
PEEP titration by EIT
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Electrical Impedance Tomography, Ventilator, Lung, Respiration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Usual care then PEEP titration by Electrical Impedance Tomography (EIT)

PEEP titration by EIT then usual care

Arm Description

Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan Acute Respiratory Distress Syndrome (ARDS) protocol high-PEEP arm

Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.

Outcomes

Primary Outcome Measures

Mechanical Power
Mechanical power (MP) is the energy imparted to the lung from the mechanical ventilator. It is calculated as listed below, where respiratory rate = RR, tidal volume = TV, Ppeak = peak airway pressure, Pplat = plateau airway pressure and PEEP = positive end-expiratory pressure. Mechanical power determined for the difference between Treatment 1 and Treatment 2. Values shown represent data gathered at the end of the designated assignment listed below, regardless of whether that assignment was Treatment 1 or Treatment 2. MP = 0.098 X RR X TV (Ppeak-[Pplat-PEEP/2])

Secondary Outcome Measures

Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio)
P/F ratio is a measurement of oxygenation and, where arterial oxygen in mmHg is PaO2 and percentage of inspired oxygen is FiO2. It calculated as: PaO2/FiO2. P/F ratio determined for the difference between Intervention 1 and Intervention 2
Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure
Plateau pressure is a measurement of lung compliance and is the airway pressure obtained during a brief inspiratory hold after delivering a tidal volume breath during invasive mechanical ventilation. Plateau pressure determined for the difference between Intervention 1 and Intervention 2
Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure
Driving pressure is the force of airway push into the lung while receiving invasive mechanical ventilation and is calculated as Plateau pressure - Positive end-expiratory pressure. Driving pressure determined for the difference between Intervention 1 and Intervention 2
Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance
Static lung compliance is a measurement of lung stiffness due to disease, with a lower compliance representing stiffer lungs. It is calculated as: Tidal volume / (Plateau pressure - PEEP). Static compliance determined for the difference between Intervention 1 and Intervention 2
Partial Pressure of Arterial Oxygen (PaO2)
PaO2 is the partial pressure of arterial oxygen measured in mmHg. PaO2 determined for the difference between Intervention 1 and Intervention 2.
Dynamic Compliance (Cdyn)
Dynamic compliance is a measurement of the resistance of the lungs and airways to gas installation from the mechanical ventilator and is measured as Peak airway pressure / Plateau airway pressure - PEEP). Dynamic compliance determined for the difference between Intervention 1 and Intervention 2.
Change in Compliance Over the Last 20% of Inspiration (C20/Dyn)
C20 is the compliance that results when only the upper 20% of the applied pressure range is taken into account. The C20/Dyn ratio appears to effectively quantitate evidence of lung over distention during mechanical ventilation. This is a unit-less measure as both numerator and denominator are measured in cm water. C20/dyn determined for the difference between Intervention 1 and Intervention 2.
Ultrasound Surrogates of Lung Aeration
Lung ultrasound inflation scores are calculated by summing regional scores (0-3 points), with higher scores indicating worse condition of the lung. Scores were obtained in six regions of each lung (i.e., up and down anterior, medial, and posterior chest wall). This is a unit-less measure. Ultrasound lung surrogates of lung inflation determined for the difference between Intervention 1 and Intervention 2.

Full Information

First Posted
January 3, 2019
Last Updated
September 18, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03793842
Brief Title
Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome
Official Title
Use of Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
June 24, 2022 (Actual)
Study Completion Date
June 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, ARDS
Keywords
Electrical Impedance Tomography, Ventilator, Lung, Respiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care then PEEP titration by Electrical Impedance Tomography (EIT)
Arm Type
Experimental
Arm Description
Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan Acute Respiratory Distress Syndrome (ARDS) protocol high-PEEP arm
Arm Title
PEEP titration by EIT then usual care
Arm Type
Experimental
Arm Description
Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.
Intervention Type
Device
Intervention Name(s)
PEEP titration by EIT
Other Intervention Name(s)
Drager PulmoVista 500 EIT System
Intervention Description
PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).
Primary Outcome Measure Information:
Title
Mechanical Power
Description
Mechanical power (MP) is the energy imparted to the lung from the mechanical ventilator. It is calculated as listed below, where respiratory rate = RR, tidal volume = TV, Ppeak = peak airway pressure, Pplat = plateau airway pressure and PEEP = positive end-expiratory pressure. Mechanical power determined for the difference between Treatment 1 and Treatment 2. Values shown represent data gathered at the end of the designated assignment listed below, regardless of whether that assignment was Treatment 1 or Treatment 2. MP = 0.098 X RR X TV (Ppeak-[Pplat-PEEP/2])
Time Frame
Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.
Secondary Outcome Measure Information:
Title
Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio)
Description
P/F ratio is a measurement of oxygenation and, where arterial oxygen in mmHg is PaO2 and percentage of inspired oxygen is FiO2. It calculated as: PaO2/FiO2. P/F ratio determined for the difference between Intervention 1 and Intervention 2
Time Frame
Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment.
Title
Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure
Description
Plateau pressure is a measurement of lung compliance and is the airway pressure obtained during a brief inspiratory hold after delivering a tidal volume breath during invasive mechanical ventilation. Plateau pressure determined for the difference between Intervention 1 and Intervention 2
Time Frame
Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment.
Title
Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure
Description
Driving pressure is the force of airway push into the lung while receiving invasive mechanical ventilation and is calculated as Plateau pressure - Positive end-expiratory pressure. Driving pressure determined for the difference between Intervention 1 and Intervention 2
Time Frame
Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.
Title
Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance
Description
Static lung compliance is a measurement of lung stiffness due to disease, with a lower compliance representing stiffer lungs. It is calculated as: Tidal volume / (Plateau pressure - PEEP). Static compliance determined for the difference between Intervention 1 and Intervention 2
Time Frame
Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment.
Title
Partial Pressure of Arterial Oxygen (PaO2)
Description
PaO2 is the partial pressure of arterial oxygen measured in mmHg. PaO2 determined for the difference between Intervention 1 and Intervention 2.
Time Frame
Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.
Title
Dynamic Compliance (Cdyn)
Description
Dynamic compliance is a measurement of the resistance of the lungs and airways to gas installation from the mechanical ventilator and is measured as Peak airway pressure / Plateau airway pressure - PEEP). Dynamic compliance determined for the difference between Intervention 1 and Intervention 2.
Time Frame
Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.
Title
Change in Compliance Over the Last 20% of Inspiration (C20/Dyn)
Description
C20 is the compliance that results when only the upper 20% of the applied pressure range is taken into account. The C20/Dyn ratio appears to effectively quantitate evidence of lung over distention during mechanical ventilation. This is a unit-less measure as both numerator and denominator are measured in cm water. C20/dyn determined for the difference between Intervention 1 and Intervention 2.
Time Frame
Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment.
Title
Ultrasound Surrogates of Lung Aeration
Description
Lung ultrasound inflation scores are calculated by summing regional scores (0-3 points), with higher scores indicating worse condition of the lung. Scores were obtained in six regions of each lung (i.e., up and down anterior, medial, and posterior chest wall). This is a unit-less measure. Ultrasound lung surrogates of lung inflation determined for the difference between Intervention 1 and Intervention 2.
Time Frame
Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endotracheal ventilation for < 1 week (168 hours) Presence of all of the following conditions for < 48 hours i. Partial pressure of oxygen to percentage of inspired oxygen (PaO2/FiO2) < 150 with PEEP > 5 cm water 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 Extracorporeal membrane oxygenation (ECMO) use Severe chronic respiratory disease requiring home oxygen therapy or ventilation Calculated BMI of greater than 50
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hyzy, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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