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Fast Breath: Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02419976
Collaborator
(none)
1,000
Enrollment
1
Location
1
Arm
107
Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators will study a noninvasive no risk process by which the investigators can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy.

Condition or Disease Intervention/Treatment Phase
  • Other: a breath analysis using the Aeonose
  • Device: Aeonose
 N/A

Detailed Description

The investigators will study a noninvasive no risk process by which we can quickly screen and assess for fasting and non-fasting states in individuals scheduled for routine endoscopy. In non-fasting individuals, the risk of a sedation related complication such as aspiration increases and often the procedure must be aborted and repeated on another day following more prolonged fasting and medication administration. This adds to increased cost and delay to patient care.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Electronic Nose Identification of Fasting and Non-fasting Breath Profiles
Study Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: fasting breath analysis

Individuals consenting to participation of this study will be asked to provide a breath analysis using the Aeonose. Following their scheduled standard of care endoscopic procedure the patient will repeat the breath analysis

Other: a breath analysis using the Aeonose
using the Aeonose per standard acquisition protocol which spans 15 minutes of which the individuals breaths normally through a sterile disposable mouthpiece with sterile disposable air filters for 10 minutes during signal acquisition while wearing a nose plug. This will be completed in the office setting prior to their endoscopic procedure. Following their scheduled standard of care endoscopic procedure the patient will be allowed to consume a standardized refreshment (such as juice or soda) prior to discharge from the post procedure area. These refreshments are already provided as standard care. The participant will return to the office setting and repeat the same breath analysis acquisition process that was done prior to the procedure.
Other Names:
  • Enose

    • Device: Aeonose

    Outcome Measures

    Primary Outcome Measures

    1. Electronically characterize what the human breath smells like during a fasting state [breath analysis obtained pre (approximately 10 minutes procedure)]

    2. Electronically characterize what the human breath smells like during a non- fasting state [breath analysis obtained post endoscopic procedure (approximately 10 minutes)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Inclusion Criteria:

    1. Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy

    2. Willing and able to consent to research protocol

    3. Fasting as required per routine instruction for upper endoscopy

    4. Able to breath for approximately 10 minutes pre and post procedure into the Aeonose device with a nose-plug on

    5. Able to consume standard refreshments post procedure during recovery per routine endoscopic area policy

    Exclusion Criteria:

    1. Non-fasting per protocol, or known to have had food or drink outside of routine protocol

    2. < 18 years of age

    3. Unable or unwilling to consent to research protocol

    4. Inability to tolerate Aeonose breathing (such as those with claustrophobia, anxiety, nasal trauma, etc.)

    5. Unable to consume refreshment post procedurally

    6. Unable to repeat Aeonose measurement post-procedurally due to tolerance or medical indication (such as instructed to remain fasting)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Kenneth K Wang, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Kenneth K. Wang, Kathy and Russ VanCleve Professor of Gastroenterology Research, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02419976
    Other Study ID Numbers:
    • 14-009226
    First Posted:
    Apr 17, 2015
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    No Results Posted as of Jan 21, 2022