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N/A N=16 Randomized Treatment

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

Acute Respiratory Distress Syndrome · ARDS

Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Mechanical Power — 1.87; -2.50 J/min — p=.002

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Usual care (Other); PEEP titration by EIT (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Jun 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Mechanical Power
1.87; -2.50 .002 sig
SECONDARY
Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio)
25.14; -0.89 0.2
SECONDARY
Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure
2.06; -2.48 0.006 sig
SECONDARY
Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure
1.34; -1.58 0.003 sig
SECONDARY
Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance
3.24; -4.6 0.008 sig
SECONDARY
Partial Pressure of Arterial Oxygen (PaO2)
SECONDARY
Dynamic Compliance (Cdyn)
SECONDARY
Change in Compliance Over the Last 20% of Inspiration (C20/Dyn)
SECONDARY
Ultrasound Surrogates of Lung Aeration

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03793842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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