N/A
N=16
Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome · ARDS
Bottom Line
View on ClinicalTrials.gov: NCT03793842 ↗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
| Outcome | Result | p-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
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.