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Detecting Lung Infections Through Vibration

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University of Florida

Status

Completed

Conditions

Lung Infection

Treatments

Procedure: Phase II Optimal Frequency
Procedure: Group 2 will receive 30 Hz
Procedure: Group 4 will receive 100 Hz
Procedure: Group 3 will receive 60 Hz
Procedure: Group 1 will receive 15 Hz

Study type

Observational

Funder types

Other

Identifiers

NCT02056860
821-2013

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 18-50

Exclusion criteria

  • History of major respiratory compromise (except cystic fibrosis if included within cystic fibrosis cohort)

Trial design

16 participants in 5 patient groups

Group 1 will receive 15 Hz
Description:
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.
Treatment:
Procedure: Group 1 will receive 15 Hz
Group 2 will receive 30 Hz
Description:
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.
Treatment:
Procedure: Group 2 will receive 30 Hz
Group 3 will receive 60 Hz
Description:
Group 3 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 60 Hz 2 .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.
Treatment:
Procedure: Group 3 will receive 60 Hz
Group 4 will receive 100 Hz
Description:
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.
Treatment:
Procedure: Group 4 will receive 100 Hz
Phase II Optimal Frequency
Description:
Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.
Treatment:
Procedure: Phase II Optimal Frequency

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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