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

Snoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05748626
• Other study ID #: STU00218263
• Status: Completed
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: October 24, 2023

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 24, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction
• Sedation Complication
• Snoring

Intervention

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.

Procedure:
• No anti -snoring device during their procedure.
For group 2 there will be no anti snoring device used during the case.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital and Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Maximum SpO2 value during the case	Maximum SpO2 value during the case using pulse oximetry	Through study completion, an average of 1 day
Secondary	Minimum SpO2 value during the case	Minimum SpO2 value during the case using pulse oximetry	Through study completion, an average of 1 day
Secondary	Heart rate maximum	Maximum heart rate during case using standard operating room cardiac monitor	Through study completion, an average of 1 day
Secondary	Heart rate minimum	Minimum heart rate during case using standard operating room cardiac monitor	Through study completion, an average of 1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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]