N/A N=20 Randomized Other

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

Spontaneous Ventilation

Bottom Line

View on ClinicalTrials.gov: NCT02930174 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Global Tidal Variation (TID) — 100; 100; 101.7; 109.1 percentage of baseline — p=0.26

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: noninvasive positive pressure ventilation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Mar 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Global Tidal Variation (TID)	100; 100; 101.7; 109.1; 131.8; 118.1	0.26
SECONDARY Regional Tidal Variation: Dorsal	56.8; 56.9; 59.0; 60.9; 69.1; 61.5	0.342
SECONDARY Regional Tidal Variation: Ventral	43.2; 43.2; 42.62; 48.2; 61.5; 56.7	0.184
SECONDARY Global Change in End-expiratory Lung Impedance (EELI)	0.00; 0.00; 45.9; 70.7; 53.3; 61.0	0.283
SECONDARY Regional Change in EELI: Dorsal	0.00; 0.00; 14.9; 18.7; 17.5; 12.0	0.204
SECONDARY Regional Change in EELI: Ventral	0.00; 0.00; 31.0; 52.0; 35.8; 49.0	0.136

Summary

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.

Eligibility Criteria

Inclusion Criteria

Age 18 years or older

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02930174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.