Anti-Snoring Appliances and Airway Manipulation in Patients Undergoing Anesthetic Sedation

Study Overview
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Brief Summary
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Would patients using an anti-snoring appliance intraoperatively require less airway manipulation, interventions, and rescue maneuvers during anesthetic sedation cases compared to those who do not? The investigators will use anti-snoring appliance devices (specifically the FDA approved Zyppah) to attempt to relieve tissue obstructions that cause snoring during sleep. The application of the devices to the body is less invasive than other common intraoperative rescue airway devices (e.g. nasal trumpets and oral airways) which are not designed to be patient specific.

Official Title
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Do Anti-Snoring Appliances Reduce the Amount of Airway Manipulation in Patients Undergoing Anesthetic Sedation? A Prospective Randomized Controlled Trial

Conditions
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Airway Obstruction, Snoring, Sedation Complication

Intervention / Treatment
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* Device: Anti-snoring device
* Procedure: No anti -snoring device during their procedure.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age 18-89 years old) Undergoing procedures below the umbilicus requiring anesthetic sedation without an invasive airway a STOP-BANG (survey) score of 2 or greater. Exclusion Criteria: Patients who are unable to consent Non-English speaking Those requiring general anesthesia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled interventional trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group #1: Anti-snoring appliance<br>Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure. | Device: Anti-snoring device<br>* For group 1, the study team will aid the subject in molding and preparing the device in the pre-operative area. They will wear the device throughout the entirety of the case.<br>|
| Active Comparator: Group #2: Control group, that will not utilize anti-snoring appliance<br>Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure. | Procedure: No anti -snoring device during their procedure.<br>* For group 2 there will be no anti snoring device used during the case.<br>* Other names: No intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined total number of airway interventions during an anesthetic sedation case | Combined total number of airway interventions during an anesthetic sedation case - including head tilt/rotation, mandible thrust, chin lift, shoulder lift, neck extension or flexion, tongue pull. | Through study completion, an average of 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum end-tidal CO2 | Maximum end-tidal CO2 using measures the partial pressure or maximal concentration of carbon dioxide (CO2) at the end of an exhaled breath, which is expressed as a percentage of CO2 or mmHg. The normal values are 5% to 6% CO2, which is equivalent to 35-45 mmHg. | Through study completion, an average of 1 day | 
| Number of times SpO2 value < 92% | Number of times the SpO2 drops below 92% during the procedure | Through study completion, an average of 1 day | 
| Minimum end-title CO2 in mmHg | Minimum end-tidal CO2 (capnography) using measures the partial pressure or maximal concentration of carbon dioxide (CO2) at the end of an exhaled breath, which is expressed as a percentage of CO2 or mmHg. The normal values are 5% to 6% CO2, which is equivalent to 35-45 mmHg. | Through study completion, an average of 1 day | 
| Percent time during the case the SpO2 is below 92% | Percent time during the case the SpO2 is below 92% using pulse oximetry. | Through study completion, an average of 1 day | 
| Maximum SpO2 value during the case | Maximum SpO2 value during the case using pulse oximetry | Through study completion, an average of 1 day | 
| Minimum SpO2 value during the case | Minimum SpO2 value during the case using pulse oximetry | Through study completion, an average of 1 day | 
| Heart rate maximum | Maximum heart rate during case using standard operating room cardiac monitor | Through study completion, an average of 1 day | 
| Heart rate minimum | Minimum heart rate during case using standard operating room cardiac monitor | Through study completion, an average of 1 day | 
| Maximum systolic blood pressure | Maximum systolic blood pressure using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day | 
| Minimum systolic blood pressure | Minimum systolic blood pressure using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day | 
| Maximum diastolic blood pressure | Maximum diastolic blood pressure using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day | 
| Minimum diastolic blood pressure | Minimum diastolic blood pressure using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day | 
| Minimum mean blood pressure | Mean minimum diastolic blood pressure using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day | 
| Maximum mean blood pressure | Maximum mean blood pressure using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day | 
| Time spent in Phase 2 PACU Recovery | Elapsed time in minutes subject spent in phase post anesthesia care unit after surgical procedure. | Through study completion, an average of 1 day] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway obstruction, Snoring, Monitored Anesthesia Care, Intravenous sedation