Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

Fasting Clinical Trial

— Fast Breath  

Official title:

Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02419976
• Other study ID #: 14-009226
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 2015
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fasting

Intervention

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.

Device:
• Aeonose

Locations

Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electronically characterize what the human breath smells like during a fasting state		breath analysis obtained pre (approximately 10 minutes procedure)
Primary	Electronically characterize what the human breath smells like during a non- fasting state		breath analysis obtained post endoscopic procedure (approximately 10 minutes)

External Links

•   Mayo Clinic Clinical Trials