At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy in Healthy Adult Human Subjects
In Brief
A clinical study evaluating Volumetric Incentive Spirometry and EzPAP® POSITIVE AIRWAY PRESSURE for Ventilation and 2 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins. * Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences. * Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause. * The 10-breath cycle will be repeated three times with respiratory therapist coaching. * Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle. * Incentive Spirometry therapy and monitoring session will last about 15 minutes
* A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only. * Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences. * Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause. * The 10-breath cycle will be repeated three times with respiratory therapist coaching. * Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle. * EzPAP® therapy and monitoring sessions will last about 15 minutes