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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.
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
November 14, 2022
Last Updated
March 6, 2023
Sponsor
Northwestern University
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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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
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
Through study completion, an average of 1 day
Secondary Outcome Measure Information:
Title
Maximum end-tidal CO2
Description
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.
Time Frame
Through study completion, an average of 1 day
Title
Number of times SpO2 value < 92%
Description
Number of times the SpO2 drops below 92% during the procedure
Time Frame
Through study completion, an average of 1 day
Title
Minimum end-title CO2 in mmHg
Description
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.
Time Frame
Through study completion, an average of 1 day
Title
Percent time during the case the SpO2 is below 92%
Description
Percent time during the case the SpO2 is below 92% using pulse oximetry.
Time Frame
Through study completion, an average of 1 day
Title
Maximum SpO2 value during the case
Description
Maximum SpO2 value during the case using pulse oximetry
Time Frame
Through study completion, an average of 1 day
Title
Minimum SpO2 value during the case
Description
Minimum SpO2 value during the case using pulse oximetry
Time Frame
Through study completion, an average of 1 day
Title
Heart rate maximum
Description
Maximum heart rate during case using standard operating room cardiac monitor
Time Frame
Through study completion, an average of 1 day
Title
Heart rate minimum
Description
Minimum heart rate during case using standard operating room cardiac monitor
Time Frame
Through study completion, an average of 1 day
Title
Maximum systolic blood pressure
Description
Maximum systolic blood pressure using standard operating room blood pressure cuff and monitor.
Time Frame
Through study completion, an average of 1 day
Title
Minimum systolic blood pressure
Description
Minimum systolic blood pressure using standard operating room blood pressure cuff and monitor.
Time Frame
Through study completion, an average of 1 day
Title
Maximum diastolic blood pressure
Description
Maximum diastolic blood pressure using standard operating room blood pressure cuff and monitor.
Time Frame
Through study completion, an average of 1 day
Title
Minimum diastolic blood pressure
Description
Minimum diastolic blood pressure using standard operating room blood pressure cuff and monitor.
Time Frame
Through study completion, an average of 1 day
Title
Minimum mean blood pressure
Description
Mean minimum diastolic blood pressure using standard operating room blood pressure cuff and monitor.
Time Frame
Through study completion, an average of 1 day
Title
Maximum mean blood pressure
Description
Maximum mean blood pressure using standard operating room blood pressure cuff and monitor.
Time Frame
Through study completion, an average of 1 day
Title
Time spent in Phase 2 PACU Recovery
Description
Elapsed time in minutes subject spent in phase post anesthesia care unit after surgical procedure.
Time Frame
Through study completion, an average of 1 day]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Fitzgerald, RN,BSN,MS
Phone
312-695-1064
Email
p-fitzgerald2@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahesh Vaidyanathan, MD,MBA
Organizational Affiliation
Northwestern Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital and Prentice Women's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahesh Vaidyanathan, MD
Phone
312-472-3585
Email
mahesh.vaidyanathan@nm.org
First Name & Middle Initial & Last Name & Degree
Paul Fitzgerald, BSN, MS
Phone
312-695-1064
Email
p-fitzgerald2@northwestern.du
First Name & Middle Initial & Last Name & Degree
Mahesh Vaidyanathan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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