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

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Acute Respiratory Distress Syndrome
ARDS

Treatments

Device: PEEP titration by EIT
Other: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT03793842
HUM00148126

Details and patient eligibility

About

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).

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

Usual care then PEEP titration by Electrical Impedance Tomography (EIT)
Experimental group
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
Treatment:
Other: Usual care
Device: PEEP titration by EIT
PEEP titration by EIT then usual care
Experimental group
Description:
Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.
Treatment:
Other: Usual care
Device: PEEP titration by EIT

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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