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Detecting Lung Infections Through Vibration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02056860
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment
Lung Infection Procedure: Group 1 will receive 15 Hz Procedure: Group 2 will receive 30 Hz Procedure: Group 3 will receive 60 Hz Procedure: Group 4 will receive 100 Hz Procedure: Phase II Optimal Frequency

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.

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Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility and Optimization of High Frequency Oscillation (HFO) for Detection of Lung Infections
Study Start Date : February 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 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.

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 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.

Group 3 will receive 60 Hz
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.
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.

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: 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.

Phase II Optimal Frequency
Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.
Procedure: Phase II Optimal Frequency
Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.




Primary Outcome Measures :
  1. Optimal Operating Conditions for HFO Device [ Time Frame: 6 months ]
    Following informed consent procedures, participants will be randomly assigned (much like a flip of a coin) to one of four experimental groups in order to test the effects of various frequencies of HFO on the size and concentration of particles obtained from EB. Group 1 (n=30) will receive 10 minutes of HFO at 15 Hz. Group 2 (n=30) will receive an identical course of HFO with the frequency set at 30 Hz. Group 3 (n=30) will receive HFO at 60 Hz and Group 4 (n=30) at 100 Hz. Participants will be tested on two separate days in order to systematically vary HFO intensity. Once again, much like a flip of a coin, each participant will be randomly assigned to receive HFO at either a low (0.75 cmH2O) or high (1.25 cm H2O) intensity on HFO Day 1. Participants receiving low intensity HFO on Day 1 will receive high intensity HFO on Day 2, and vice versa. Between HFO Testing Day 1 and 2 there will be a washout period of at least 24 hours.


Secondary Outcome Measures :
  1. Particle size and distribution from exhaled breath [ Time Frame: One year ]
    The exhaled air will be directed to a culturing media in place of the Sizer for collection of the droplets during two conditions: tidal breathing without oscillation (control) and tidal breathing with oscillation (experimental). The samples collected in the medium will later be cultured in a lab to determine the microbial species and their abundances. The purpose of Phase II experiments is to characterize the biological constituents produced from the oscillation enhanced sampling and contrast these constituents with those obtained during non-oscillation enhanced sampling. We hope to determine if the addition of oscillation increases the variety and abundance of microbial species able to be extracted from exhaled breath.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy normal adults age 18 to 50 Individuals with cystic fibrosis
Criteria

Inclusion Criteria:

  • Age 18-50

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056860


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Erin P Silverman, PhD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02056860    
Other Study ID Numbers: 821-2013
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Afshar-Mohajer N, Wu CY, Tsai HW, Silverman E, Davenport P, Hegde S. Optimizing an Internal Airway Percussion Device for Facilitating Exhalate Diagnostics of the Human Respiratory System. J Aerosol Med Pulm Drug Deliv. 2015 Mar 31. [Epub ahead of print] PubMed PMID: 25826647.
Keywords provided by University of Florida:
cystic fibrosis
Additional relevant MeSH terms:
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Infection
Communicable Diseases