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

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.

Study Overview

• Status: Terminated
• Conditions: Fasting
• Intervention / Treatment: Device: Aeonose; Other: a breath analysis using the Aeonose

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 Type: Interventional
• Enrollment (Actual): 879
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: Aeonose; 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 5 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile	Exhaled Volatile Organic Compounds (VOCs) were collected by subject's breathing into a non-invasive breath analyzer (Aeonose) for 5 minutes by which through pattern recognition electronic changes can be identified in exhaled volatile organic compounds interfacing with an electronic sensor that creates an electronic signature, or smell-print that distinguishes the fasting and non-fasting states. The effectiveness of the Aeonose in distinguishing subjects in a fasting versus non-fasting state is represented by the device's sensitivity and specificity (ability to positively identify subjects who are in a fasting state versus non-fasting state).	breath analysis obtained (approximately 10 minutes procedure)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Cadman Leggett, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): June 20, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 16, 2015
• First Posted (Estimated): April 17, 2015

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Fasting
• Other Study ID Numbers: 14-009226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No