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

Primary Purpose

Airway Obstruction, Snoring, Sedation Complication

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Anti-snoring device

No anti -snoring device during their procedure.

About this trial

This is an interventional treatment trial for Airway Obstruction focused on measuring Airway obstruction, Snoring, Monitored Anesthesia Care, Intravenous sedation

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Northwestern Memorial Hospital and Prentice Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group #1: Anti-snoring appliance

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Number of times SpO2 value < 92%

Number of times the SpO2 drops below 92% during the procedure

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.

Percent time during the case the SpO2 is below 92%

Percent time during the case the SpO2 is below 92% using pulse oximetry.

Maximum SpO2 value during the case

Maximum SpO2 value during the case using pulse oximetry

Minimum SpO2 value during the case

Minimum SpO2 value during the case using pulse oximetry

Heart rate maximum

Maximum heart rate during case using standard operating room cardiac monitor

Heart rate minimum

Minimum heart rate during case using standard operating room cardiac monitor

Maximum systolic blood pressure

Maximum systolic blood pressure using standard operating room blood pressure cuff and monitor.

Minimum systolic blood pressure

Minimum systolic blood pressure using standard operating room blood pressure cuff and monitor.

Maximum diastolic blood pressure

Maximum diastolic blood pressure using standard operating room blood pressure cuff and monitor.

Minimum diastolic blood pressure

Minimum diastolic blood pressure using standard operating room blood pressure cuff and monitor.

Minimum mean blood pressure

Mean minimum diastolic blood pressure using standard operating room blood pressure cuff and monitor.

Maximum mean blood pressure

Maximum mean blood pressure using standard operating room blood pressure cuff and monitor.

Time spent in Phase 2 PACU Recovery

Elapsed time in minutes subject spent in phase post anesthesia care unit after surgical procedure.

Full Information

NCT ID

NCT05748626

First Posted

November 14, 2022

Last Updated

March 6, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT05748626

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 6, 2023 (Actual)

Primary Completion Date

August 30, 2024 (Anticipated)

Study Completion Date

September 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Airway Obstruction, Snoring, Sedation Complication

Keywords

Airway obstruction, Snoring, Monitored Anesthesia Care, Intravenous sedation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled interventional trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group #1: Anti-snoring appliance

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Anti-snoring device

Intervention Description

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

Procedure

Intervention Name(s)

No anti -snoring device during their procedure.

Other Intervention Name(s)

No intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Combined total number of airway interventions during an anesthetic sedation case

Description

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.

Time Frame