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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2023-10-24

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.

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Detailed Description

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Conditions

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Airway Obstruction Snoring Sedation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled interventional trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group #1: Anti-snoring appliance

Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure.

Group Type EXPERIMENTAL

Anti-snoring device

Intervention Type DEVICE

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.

Group #2: Control group, that will not utilize anti-snoring appliance

Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure.

Group Type ACTIVE_COMPARATOR

No anti -snoring device during their procedure.

Intervention Type PROCEDURE

For group 2 there will be no anti snoring device used during the case.

Interventions

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Anti-snoring device

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.

Intervention Type DEVICE

No anti -snoring device during their procedure.

For group 2 there will be no anti snoring device used during the case.

Intervention Type PROCEDURE

Other Intervention Names

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No intervention

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.