Trial Outcomes & Findings for EIT Assessment of Lung Volume and Tidal Distribution: A Comparison of Non-Invasive Ventilation Devices (NCT NCT02930174)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

1 day

Results posted on

2019-05-14

Participant Flow

Volunteers were solicited via word of mouth from the medical staff and the respiratory therapy staff at our university hospital. Enrollment occurred from February 1, 2018 through March 27, 2018.

All volunteers were screened for any contraindication to applying the electrical impedance tomography device (pacemaker, etc) before signing an informed consent document. No volunteer had such contraindications and all were successfully studied.

Participant milestones

Participant milestones
Measure	Device 1, Then Device 2 Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2) in a crossover study Device 1 is a continuous high flow, blower type of generator.	Device 2, Then Device 1 Testing by applying noninvasive positive pressure ventilation (NPPV) via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2) in a crossover study Device 2 is a critical care ventilator that has a specific NPPV mode.
Overall Study STARTED	12	8
Overall Study COMPLETED	12	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device 1, Then Device 2 n=12 Participants Testing by applying noninvasive positive pressure ventilation via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2) Device 1 is a continuous high flow, blower type of generator.	Device 2, Then Device 1 n=8 Participants Testing by applying noninvasive positive pressure ventilation via two different bilevel positive airway pressure (BiPAP) devices: Respironics V-60 (Device 1) and Drager V-500 (Device 2). Device 2 is a critical care ventilator that has a specific NPPV mode.	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=8 Participants	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=12 Participants	7 Participants n=8 Participants	18 Participants n=20 Participants
Age, Categorical >=65 years	1 Participants n=12 Participants	1 Participants n=8 Participants	2 Participants n=20 Participants
Age, Continuous	41.8 years STANDARD_DEVIATION 13.2 • n=12 Participants	43.8 years STANDARD_DEVIATION 14.4 • n=8 Participants	42.6 years STANDARD_DEVIATION 1.3 • n=20 Participants
Sex: Female, Male Female	0 Participants n=12 Participants	0 Participants n=8 Participants	0 Participants n=20 Participants
Sex: Female, Male Male	12 Participants n=12 Participants	8 Participants n=8 Participants	20 Participants n=20 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	8 participants n=8 Participants	20 participants n=20 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Respironics V-60 n=20 Participants This device is a continuous high flow, blower type of generator.	Draeger V-500 n=20 Participants This device is an ICU ventilator
Global Tidal Variation (TID) Baseline (no pressure)	100 percentage of baseline Standard Deviation 0	100 percentage of baseline Standard Deviation 0
Global Tidal Variation (TID) Continuous Positive Airway Pressure (CPAP) 5	101.7 percentage of baseline Standard Deviation 16.4	109.1 percentage of baseline Standard Deviation 22.1
Global Tidal Variation (TID) Pressure Support (PS) 5, CPAP 5	131.8 percentage of baseline Standard Deviation 39.5	118.1 percentage of baseline Standard Deviation 32.8
Global Tidal Variation (TID) PS 5, CPAP 10	128.6 percentage of baseline Standard Deviation 47.0	126.4 percentage of baseline Standard Deviation 45.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Respironics V-60 n=20 Participants This device is a continuous high flow, blower type of generator.	Draeger V-500 n=20 Participants This device is an ICU ventilator
Regional Tidal Variation: Dorsal Baseline (no pressure)	56.8 percentage of global TID Standard Deviation 14.0	56.9 percentage of global TID Standard Deviation 12.4
Regional Tidal Variation: Dorsal CPAP 5	59.0 percentage of global TID Standard Deviation 19.4	60.9 percentage of global TID Standard Deviation 18.4
Regional Tidal Variation: Dorsal PS 5, CPAP 5	69.1 percentage of global TID Standard Deviation 31.1	61.5 percentage of global TID Standard Deviation 22.0
Regional Tidal Variation: Dorsal PS 5, CPAP 10	71.3 percentage of global TID Standard Deviation 39.8	67.0 percentage of global TID Standard Deviation 32.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Respironics V-60 n=20 Participants This device is a continuous high flow, blower type of generator.	Draeger V-500 n=20 Participants This device is an ICU ventilator
Regional Tidal Variation: Ventral Baseline (no pressure)	43.2 percentage of global TID Standard Deviation 14.0	43.2 percentage of global TID Standard Deviation 12.5
Regional Tidal Variation: Ventral CPAP 5	42.62 percentage of global TID Standard Deviation 12.8	48.2 percentage of global TID Standard Deviation 21.0
Regional Tidal Variation: Ventral PS 5, CPAP 5	61.5 percentage of global TID Standard Deviation 22.0	56.7 percentage of global TID Standard Deviation 25.7
Regional Tidal Variation: Ventral PS 5, CPAP 10	67.0 percentage of global TID Standard Deviation 32.9	59.5 percentage of global TID Standard Deviation 24.9

SECONDARY outcome

Timeframe: 1 day

Population: Because one subject's EELI data did not record properly on device 2, that subject's data was excluded from analysis for both arms.

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.

Outcome measures

Outcome measures
Measure	Respironics V-60 n=19 Participants This device is a continuous high flow, blower type of generator.	Draeger V-500 n=19 Participants This device is an ICU ventilator
Global Change in End-expiratory Lung Impedance (EELI) Baseline (no pressure)	0.00 percentage change from baseline Standard Deviation 0.00	0.00 percentage change from baseline Standard Deviation 0.00
Global Change in End-expiratory Lung Impedance (EELI) CPAP 5	45.9 percentage change from baseline Standard Deviation 28.9	70.7 percentage change from baseline Standard Deviation 68.9
Global Change in End-expiratory Lung Impedance (EELI) PS 5, CPAP 5	53.3 percentage change from baseline Standard Deviation 33.3	61.0 percentage change from baseline Standard Deviation 53.7
Global Change in End-expiratory Lung Impedance (EELI) PS 5, CPAP 10	135.2 percentage change from baseline Standard Deviation 65.6	141.0 percentage change from baseline Standard Deviation 101.3

SECONDARY outcome

Timeframe: 1 day

Population: Because one subject's EELI data did not record properly on device 2, that subject's data was excluded from analysis for both arms.

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

Outcome measures

Outcome measures
Measure	Respironics V-60 n=19 Participants This device is a continuous high flow, blower type of generator.	Draeger V-500 n=19 Participants This device is an ICU ventilator
Regional Change in EELI: Dorsal Baleline (no pressure)	0.00 percentage change from baseline Standard Deviation 0.00	0.00 percentage change from baseline Standard Deviation 0.00
Regional Change in EELI: Dorsal CPAP 5	14.9 percentage change from baseline Standard Deviation 13.8	18.7 percentage change from baseline Standard Deviation 31.2
Regional Change in EELI: Dorsal PS 5, CPAP 5	17.5 percentage change from baseline Standard Deviation 15.8	12.0 percentage change from baseline Standard Deviation 26.3
Regional Change in EELI: Dorsal PS 5, CPAP 10	44.9 percentage change from baseline Standard Deviation 27.3	36.4 percentage change from baseline Standard Deviation 43.8

SECONDARY outcome

Timeframe: 1 day

Population: Because one subject's EELI data did not record properly on device 2, that subject's data was excluded from analysis for both arms.

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

Outcome measures

Outcome measures
Measure	Respironics V-60 n=19 Participants This device is a continuous high flow, blower type of generator.	Draeger V-500 n=19 Participants This device is an ICU ventilator
Regional Change in EELI: Ventral Baseline (no pressure)	0.00 percentage change from baseline Standard Deviation 0.00	0.00 percentage change from baseline Standard Deviation 0.00
Regional Change in EELI: Ventral CPAP 5	31.0 percentage change from baseline Standard Deviation 19.1	52.0 percentage change from baseline Standard Deviation 47.9
Regional Change in EELI: Ventral PS 5, CPAP 5	35.8 percentage change from baseline Standard Deviation 21.9	49.0 percentage change from baseline Standard Deviation 40.2
Regional Change in EELI: Ventral PS 5, CPAP 10	90.3 percentage change from baseline Standard Deviation 43.2	104.5 percentage change from baseline Standard Deviation 72.8

Adverse Events

Volunteer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carl Haas

University of Michigan Health System

Phone: 734-936-5234

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place