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Completed

NCT Number: NCT02930174

EIT Assessment of Lung Volume and Tidal Distribution: A Comparison of Non-Invasive Ventilation Devices

This study is being done to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.

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Key information

Conditions

Spontaneous Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

Mechanical ventilation is life-saving technology but it can also inadvertently induce lung injury and increase morbidity and mortality. There currently is not an easy method of assessing the impact ventilator settings have on the degree of lung inflation. Computed tomography (CT), the gold standard for visually monitoring lung function, can provide detailed regional information of the lung. Unfortunately, it necessitates moving critically ill patients to a special diagnostic room and involves exposure to radiation like an X-ray.

A technique introduced in the 1980's, electrical impedance tomography (EIT), can non-invasively provide similar monitoring of lung function, and without the exposure to radiation. This imaging technique applies small alternating currents of electricity to surface electrodes to construct cross-sectional images of the lung.

Over that past several decades EIT has moved from the research lab to commercially available devices that are used at the bedside. EIT has also been applied to study the effects of various devices used to provide non-invasive ventilation. EIT may prove useful to optimally adjust non-invasive ventilation settings to improve ventilation and oxygenation. One such EIT system is manufactured by Draeger Medical. It is available in Europe and Canada but is not yet FDA approved for use in the United States.

This study is being done with healthy volunteers to further the investigators' knowledge of the EIT system and to see if measures between two non-invasive ventilation systems routinely used clinically are equivalent.

As this is a preliminary study looking at the EIT system vs 2 other devices, outcomes measures may be modified as the study progresses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older

Exclusion criteria

  • Use of a cardiac pacemaker, an implantable cardioverter-defibrillator (ICD) or any other active implants

Treatment and study plan

Noninvasive Positive Pressure Ventilation

Device

Application of various levels of positive pressure

Primary outcomes

  1. Global Tidal Variation (TID)

    Time frame: 1 day

    TID is the distribution of ventilation for a breath averaged over a defined section, the entire lung. TID is analogous to the tidal volume. Baseline is defined to be 100% and other measures are in comparison to baseline (eg, a value of 102 represents a 2% increase from baseline).

Secondary outcomes

  1. Regional Tidal Variation: Dorsal

    Time frame: 1 day

    Distribution of ventilation for a breath averaged over a defined section, the dorsal lung regions. Reflects the percent of tidal volume distributed to that area.

  2. Regional Tidal Variation: Ventral

    Time frame: 1 day

    Distribution of ventilation for a breath averaged over a defined section, the ventral lung regions. Reflects the percent of tidal volume distributed to that area.

  3. Global Change in End-expiratory Lung Impedance (EELI)

    Time frame: 1 day

    EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume.

    The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied.

    By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device.

  4. Regional Change in EELI: Dorsal

    Time frame: 1 day

    EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume.

    The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied.

    By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device

  5. Regional Change in EELI: Ventral

    Time frame: 1 day

    EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume.

    The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied.

    By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2016
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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