NCT02056860

Detecting Lung Infections Through Vibration

Feasibility and Optimization of High Frequency Oscillation (HFO) for Detection of Lung Infections

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test a lung air vibrator device for vibrating air inside the lung. This exploratory diagnostic trial will test a novel and non-invasive means of detecting lower airway infections using exhaled breath sample.

Detailed description

This study has two phases. Once the subject has consented phase 1 will start by the subject breathing air out of their lungs into the device. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air. In phase 2, the subjects will breathe air out of their lungs into the device for 15 minutes. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air for 15 minutes.

Conditions

• Lung Infection

Interventions

Type	Name	Description
PROCEDURE	Group 1 will receive 15 Hz	Group 1 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 15 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 15 Hz at 1.25 cm.
PROCEDURE	Group 2 will receive 30 Hz	Group 2 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 30 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 30 Hz 1.25 cm.
PROCEDURE	Group 3 will receive 60 Hz	Group 3 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 60 Hz .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 60 Hz at 1.25 cm.
PROCEDURE	Group 4 will receive 100 Hz	Group 4 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 100 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 100 Hz at 1.25 cm.
PROCEDURE	Phase II Optimal Frequency	Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-02-06
• Last updated: 2016-03-16

Locations

1 site across 1 country: United States