N/A
N=30
Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy
Ventilation · Breathing · Atelectasis
Bottom Line
View on ClinicalTrials.gov: NCT03083379 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Regional Distribution of Ventilation — -4.9; -5.6 percentage of dorsal redistribution — p=.90
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Volumetric Incentive Spirometry (Device); EzPAP® POSITIVE AIRWAY PRESSURE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Regional Distribution of Ventilation |
-4.9; -5.6 | .90 |
Summary
The primary purpose of this study is to determine if there is a significant difference in regional distribution of ventilation when comparing eupneic tidal ventilation with Incentive Spirometry (I.S.) and EzPAP® lung expansion therapy in healthy adult human subjects. Electrical impedance tomography (EIT) will be used to measure regional distribution of ventilation during resting tidal ventilation and during lung expansion therapy.
Eligibility Criteria
Inclusion Criteria
- Healthy- not receiving in-patient medical care
- Documentation of written informed consent
Exclusion Criteria
- Less than 18 or greater than 79 years of age
- Body mass index > 50
- Excessive chest hair
- Inability to obtain written informed consent
- Inability to follow verbal instructions
- Pregnancy: self reported
- Uncontrolled body movements
- Inability to place EIT electrodes and belt in direct contact with skin where they are projected to come into contact
- Active implants (i.e., cardiac pacemaker, implantable cardioverter-defibrillator [ICD]), or when device compatibility is in doubt.)
Data sourced from ClinicalTrials.gov (NCT03083379). 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.