Fasting
Conditions
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.
Interventions
OTHERa 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.
DEVICEAeonose
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the Aeonose in Distinguishing a Fasting Versus Non-fasting Breath Profile | breath analysis obtained (approximately 10 minutes procedure) | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCadman Leggett, MD
Mayo Clinic
Participant flow
Pre-assignment details
The protocol required classifying subjects as fasting or non-fasting, but only 185 fasting and 33 non-fasting subjects can be reported. As the data field in the study database designated to record fasting status was not implemented consistently throughout the study, fasting information was as a result not collected for the majority of enrolled subjects. The study team cannot retrospectively determine or report fasting status for the remaining subjects.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 423 Participants |
| Age, Categorical Between 18 and 65 years | 456 Participants |
| Age, Continuous | 44 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 780 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 89 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 77 Participants |
| Race (NIH/OMB) White | 786 Participants |
| Region of Enrollment United States | 879 participants |
| Sex: Female, Male Female | 331 Participants |
| Sex: Female, Male Male | 548 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed