NCT03793842

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

Completed NA Results posted Last updated 12 October 2023

What this trial tests

NA trial testing Usual care in Acute Respiratory Distress Syndrome in 16 participants. Completed in 24 June 2022.

Timeline

4 March 2019

Primary endpoint
24 June 2022

24 June 2022

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	4 March 2019
Primary completion	24 June 2022
Estimated completion	24 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Usual care
• PEEP titration by EIT

Conditions studied

• Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
• ARDS — all drugs for ARDS →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Acute Respiratory Distress Syndrome or ARDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mechanical Power Primary · 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-\[Pplat-PEEP/2\])

Group	Value	95% CI
PEEP	1.87	± 1.61
Usual Care	-2.50	± 3.7

Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio) Secondary · 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.

P/F ratio is a measurement of oxygenation and, where arterial oxygen in mmHg is PaO2 and percentage of inspired oxygen is FiO2. It calculated as: PaO2/FiO2. P/F ratio determined for the difference between Intervention 1 and Intervention 2

Group	Value	95% CI
PEEP	25.14	± 27.11
Usual Care	-0.89	± 60.05

Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure Secondary · 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.

Plateau pressure is a measurement of lung compliance and is the airway pressure obtained during a brief inspiratory hold after delivering a tidal volume breath during invasive mechanical ventilation. Plateau pressure determined for the difference between Intervention 1 and Intervention 2

Group	Value	95% CI
PEEP	2.06	± 1.88
Usual Care	-2.48	± 3.22

Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure Secondary · 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.

Driving pressure is the force of airway push into the lung while receiving invasive mechanical ventilation and is calculated as Plateau pressure - Positive end-expiratory pressure. Driving pressure determined for the difference between Intervention 1 and Intervention 2

Group	Value	95% CI
PEEP	1.34	± 1.31
Usual Care	-1.58	± 2.32

Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance Secondary · 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.

Static lung compliance is a measurement of lung stiffness due to disease, with a lower compliance representing stiffer lungs. It is calculated as: Tidal volume / (Plateau pressure - PEEP). Static compliance determined for the difference between Intervention 1 and Intervention 2

Group	Value	95% CI
PEEP	3.24	± 9.85
Usual Care	-4.6	± 5.26

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Electric impedance tomography-guided PEEP titration reduces mechanical power in ARDS: a randomized crossover pilot trial.
   Jimenez JV, Munroe E, Weirauch AJ, Fiorino K, et al · · 2023 · cited 37× · PMID 36650593 · DOI 10.1186/s13054-023-04315-x