Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

Study Overview
=================
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.

Official Title
-----------------
Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

Conditions
-----------------
Fasting

Intervention / Treatment
-----------------
* Other: a breath analysis using the Aeonose
* Device: Aeonose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: Adult (18+) patient undergoing scheduled elective outpatient upper endoscopy Willing and able to consent to research protocol Fasting as required per routine instruction for upper endoscopy Able to breath for approximately 10 minutes pre and post procedure into the Aeonose device with a nose-plug on Able to consume standard refreshments post procedure during recovery per routine endoscopic area policy Exclusion Criteria: Non-fasting per protocol, or known to have had food or drink outside of routine protocol < 18 years of age Unable or unwilling to consent to research protocol Inability to tolerate Aeonose breathing (such as those with claustrophobia, anxiety, nasal trauma, etc.) Unable to consume refreshment post procedurally Unable to repeat Aeonose measurement post-procedurally due to tolerance or medical indication (such as instructed to remain fasting)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fasting breath analysis<br>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<br>* 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.<br>* Other names: Enose;Device: Aeonose<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |