Clinical trial NCT05748626: 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
Overall status: COMPLETED
Phase: NA
Conditions: Airway Obstruction
Snoring
Sedation Complication
Keywords: Airway obstruction
Snoring
Monitored Anesthesia Care
Intravenous sedation
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled interventional trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Combined total number of airway interventions during an anesthetic sedation case
timeFrame: Through study completion, an average of 1 day
Secondary outcomes:
measure: Maximum end-tidal CO2
timeFrame: Through study completion, an average of 1 day
measure: Number of times SpO2 value < 92%
timeFrame: Through study completion, an average of 1 day
measure: Minimum end-title CO2 in mmHg
timeFrame: Through study completion, an average of 1 day
measure: Percent time during the case the SpO2 is below 92%
timeFrame: Through study completion, an average of 1 day
measure: Maximum SpO2 value during the case
timeFrame: Through study completion, an average of 1 day
measure: Minimum SpO2 value during the case
timeFrame: Through study completion, an average of 1 day
measure: Heart rate maximum
timeFrame: Through study completion, an average of 1 day
measure: Heart rate minimum
timeFrame: Through study completion, an average of 1 day
measure: Maximum systolic blood pressure
timeFrame: Through study completion, an average of 1 day
measure: Minimum systolic blood pressure
timeFrame: Through study completion, an average of 1 day
measure: Maximum diastolic blood pressure
timeFrame: Through study completion, an average of 1 day
measure: Minimum diastolic blood pressure
timeFrame: Through study completion, an average of 1 day
measure: Minimum mean blood pressure
timeFrame: Through study completion, an average of 1 day
measure: Maximum mean blood pressure
timeFrame: Through study completion, an average of 1 day
measure: Time spent in Phase 2 PACU Recovery
timeFrame: Through study completion, an average of 1 day]
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital and Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern Univesity
name: Mahesh Vaidyanathan, MD,MBA
role: PRINCIPAL_INVESTIGATOR
References: