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

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

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.

Study Overview

• Status: Completed
• Conditions: Snoring; Airway Obstruction; Sedation Complication
• Intervention / Treatment: Device: Anti-snoring device; Procedure: No anti -snoring device during their procedure.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital and Prentice Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group #1: Anti-snoring appliance; Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure.	Device: 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.
Active Comparator: 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.	Procedure: No anti -snoring device during their procedure.; For group 2 there will be no anti snoring device used during the case.; Other Names: No intervention

What is the study measuring?

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]

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Mahesh Vaidyanathan, MD,MBA, Northwestern Univesity

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): October 24, 2023

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: February 25, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Intravenous sedation; Snoring; Airway obstruction; Monitored Anesthesia Care
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Sounds; Respiratory Insufficiency; Snoring; Airway Obstruction
• Other Study ID Numbers: STU00218263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No