NCT02419976

Electronic Nose Identification of Fasting and Non-fasting Breath Profiles

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 879 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fasting

Interventions

Type	Name	Description
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.
DEVICE	Aeonose

Timeline

• Start date: 2015-02-01
• Primary completion: 2024-06-20
• Completion: 2024-06-20
• First posted: 2015-04-17
• Last updated: 2026-01-26
• Results posted: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study