Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

Not Applicable

Terminated

• Conditions: Fasting
• Interventions: Other: a breath analysis using the Aeonose; Device: Aeonose

• Registration Number: NCT02419976
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-17
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 879

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

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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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fasting breath analysis	a breath analysis using the Aeonose	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
fasting breath analysis	Aeonose	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

Primary Outcome Measures

Name	Time	Method
Electronically characterize what the human breath smells like during a fasting state	breath analysis obtained pre (approximately 10 minutes procedure)
Electronically characterize what the human breath smells like during a non- fasting state	breath analysis obtained post endoscopic procedure (approximately 10 minutes)

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States