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

Not Applicable

Completed

• Conditions: Snoring; Airway Obstruction; Sedation Complication

• Registration Number: NCT05748626
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2023-02-25
• Study First Posted: 2023-03-01
• Study Start: 2023-03-06
• Primary Completion: 2023-08-30
• Study Completion: 2023-10-24
• Results First Submitted: 2025-06-18
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Results First Posted: 2025-08-14
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Combined Total Number of Airway Interventions During an Anesthetic Sedation Case	Through study completion, an average of 1 day	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.

Secondary Outcome Measures

Name	Time	Method
Maximum End-tidal CO2	Through study completion, an average of 1 day	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.
Heart Rate Minimum	Through study completion, an average of 1 day	Minimum heart rate during case using standard operating room cardiac monitor
Maximum Systolic Blood Pressure	Through study completion, an average of 1 day	Maximum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.
Minimum Systolic Blood Pressure	Through study completion, an average of 1 day	Minimum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.
Maximum Diastolic Blood Pressure	Through study completion, an average of 1 day	Maximum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Minimum Diastolic Blood Pressure	Through study completion, an average of 1 day	Minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Number of Instances SpO2 Value < 92%	Through study completion, an average of 1 day	Number of instances the SpO2 drops below 92% during the procedure
Minimum End-title CO2 in mmHg	Through study completion, an average of 1 day	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.
Percent Time During the Case the SpO2 is Below 92%	Through study completion, an average of 1 day	Percent time during the case the SpO2 is below 92% using pulse oximetry.
Maximum SpO2 Value During the Case	Through study completion, an average of 1 day	Maximum SpO2 value during the case using pulse oximetry (percent saturated)
Minimum SpO2 Value During the Case	Through study completion, an average of 1 day	Minimum SpO2 value during the case using pulse oximetry (percent saturation)
Heart Rate Maximum	Through study completion, an average of 1 day	Maximum heart rate during case using standard operating room cardiac monitor
Minimum Mean Blood Pressure	Through study completion, an average of 1 day	Mean minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Reintubation in the Post Anesthesia Care Unit	1 Day	Number of participants requiring reintubation with an endotracheal tube post surgery in the Post Anesthesia Care Unit
Surgical Length of Time	1 day	Surgical length of time in hours.
Maximum Mean Blood Pressure	Through study completion, an average of 1 day	Maximum mean blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.

Trial Locations

Locations (1)

Northwestern Memorial Hospital and Prentice Women's Hospital; 🇺🇸 Chicago, Illinois, United States