Electronic Nose Identification of Fasting and Non-fasting Breath Profiles (Fast Breath)

Mayo Clinic

Status: Terminated

Conditions: Fasting

Treatments: Device: Aeonose; Other: a breath analysis using the Aeonose

Study type: Interventional

Funder types: Other

Identifiers

NCT02419976

14-009226

Details and patient eligibility

About

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.

Full 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.

Enrollment: 879 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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879 participants in 1 patient group

fasting breath analysis

Experimental group

Description:

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

Treatment:

Other: a breath analysis using the Aeonose

Device: Aeonose