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Clinical Trials/NCT03793842
NCT03793842
Completed
Not Applicable

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

University of Michigan1 site in 1 country16 target enrollmentMarch 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Distress Syndrome
Sponsor
University of Michigan
Enrollment
16
Locations
1
Primary Endpoint
Mechanical Power
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 4, 2019
End Date
June 24, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert C. Hyzy, MD

Professor of Internal Medicine

University of Michigan

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

Outcomes

Primary Outcomes

Mechanical Power

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.

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 Outcomes

  • Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio)(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.)
  • Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure(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.)
  • Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure(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.)
  • Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance(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.)
  • Dynamic Compliance (Cdyn)(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.)
  • Ultrasound Surrogates of Lung Aeration(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.)
  • Change in Compliance Over the Last 20% of Inspiration (C20/Dyn)(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.)
  • Partial Pressure of Arterial Oxygen (PaO2)(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.)

Study Sites (1)

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