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

NCT03793842 | Completed Results FDA Device

• 1 other identifier: HUM00148126
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Respiratory Distress Syndrome; ARDS

Keywords

Electrical Impedance Tomography; Ventilator; Lung; Respiration

Outcome Measures

Primary Outcomes (1)

• Mechanical Power

  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-\[Pplat-PEEP/2\])

  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 (8)

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

  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.

• Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure

  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.

• Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure

  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.

• Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance

  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.

• Partial Pressure of Arterial Oxygen (PaO2)

  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.

Study Arms (2)

Usual care then PEEP titration by Electrical Impedance Tomography (EIT)

EXPERIMENTAL

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

Other: Usual care; Device: PEEP titration by EIT

PEEP titration by EIT then usual care

EXPERIMENTAL

Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure.

Other: Usual care; Device: PEEP titration by EIT

Interventions

Usual care OTHER

Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.

PEEP titration by EIT then usual care; Usual care then PEEP titration by Electrical Impedance Tomography (EIT)

PEEP titration by EIT DEVICE

PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).

Also known as: Drager PulmoVista 500 EIT System

PEEP titration by EIT then usual care; Usual care then PEEP titration by Electrical Impedance Tomography (EIT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Jimenez JV, Munroe E, Weirauch AJ, Fiorino K, Culter CA, Nelson K, Labaki WW, Choi PJ, Co I, Standiford TJ, Prescott HC, Hyzy RC. Electric impedance tomography-guided PEEP titration reduces mechanical power in ARDS: a randomized crossover pilot trial. Crit Care. 2023 Jan 17;27(1):21. doi: 10.1186/s13054-023-04315-x.

  PMID: 36650593 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robert Hyzy, MD
• Organization: Michigan Medicine

rhyzy@med.umich.edu

734-936-5201

Study Officials

• Robert Hyzy, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 4, 2019
• Study Start: March 4, 2019
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: October 12, 2023
• Results First Posted: October 12, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)