Clinical trial NCT03793842: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
ARDS
Keywords: Electrical Impedance Tomography
Ventilator
Lung
Respiration
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Mechanical Power
timeFrame: 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 outcomes:
measure: Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio)
timeFrame: 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.
measure: Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure
timeFrame: 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.
measure: Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure
timeFrame: 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.
measure: Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance
timeFrame: 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.
measure: Partial Pressure of Arterial Oxygen (PaO2)
timeFrame: 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.
measure: Dynamic Compliance (Cdyn)
timeFrame: 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.
measure: Change in Compliance Over the Last 20% of Inspiration (C20/Dyn)
timeFrame: 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.
measure: Ultrasound Surrogates of Lung Aeration
timeFrame: 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.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Robert Hyzy, MD
role: PRINCIPAL_INVESTIGATOR
References: