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

Not Applicable

Completed

• Conditions: Snoring; Airway Obstruction; Sedation Complication
• Interventions: Procedure: No anti -snoring device during their procedure.; Device: Anti-snoring device

• 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
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

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

Arm && Interventions

Group	Intervention	Description
Group #2: Control group, that will not utilize anti-snoring appliance	No anti -snoring device during their procedure.	Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure.
Group #1: Anti-snoring appliance	Anti-snoring device	Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure.

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
Number of times SpO2 value < 92%	Through study completion, an average of 1 day	Number of times the SpO2 drops below 92% during the procedure
Maximum systolic blood pressure	Through study completion, an average of 1 day	Maximum systolic blood pressure using standard operating room blood pressure cuff and monitor.
Heart rate maximum	Through study completion, an average of 1 day	Maximum heart rate during case using standard operating room cardiac monitor
Maximum mean blood pressure	Through study completion, an average of 1 day	Maximum mean blood pressure using standard operating room blood pressure cuff and monitor.
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.
Maximum SpO2 value during the case	Through study completion, an average of 1 day	Maximum SpO2 value during the case using pulse oximetry
Heart rate minimum	Through study completion, an average of 1 day	Minimum heart rate during case using standard operating room cardiac monitor
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.
Minimum SpO2 value during the case	Through study completion, an average of 1 day	Minimum SpO2 value during the case using pulse oximetry
Minimum diastolic blood pressure	Through study completion, an average of 1 day	Minimum diastolic blood pressure using standard operating room blood pressure cuff and monitor.
Minimum mean blood pressure	Through study completion, an average of 1 day	Mean minimum diastolic blood pressure using standard operating room blood pressure cuff and monitor.
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.
Minimum systolic blood pressure	Through study completion, an average of 1 day	Minimum systolic blood pressure using standard operating room blood pressure cuff and monitor.
Time spent in Phase 2 PACU Recovery	Through study completion, an average of 1 day]	Elapsed time in minutes subject spent in phase post anesthesia care unit after surgical procedure.
Maximum diastolic blood pressure	Through study completion, an average of 1 day	Maximum diastolic blood pressure 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