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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group #1: Anti-snoring appliance | Experimental | Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure. |
|
| Group #2: Control group, that will not utilize anti-snoring appliance | Active Comparator | Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-snoring device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mahesh Vaidyanathan, MD,MBA | Northwestern Univesity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital and Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28077547 | Result | Lacquiere DA, Hodzovic I, Woollard A, Varvinskiy A, Chishti K, Hughes R. DAS 2015 guidelines for management of CICO. Br J Anaesth. 2016 Oct;117(4):532-533. doi: 10.1093/bja/aew285. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group #1: Anti-snoring Appliance | Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure. 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. |
| FG001 | Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance | Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure. No anti -snoring device during their procedure.: For group 2 there will be no anti snoring device used during the case. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group #1: Anti-snoring Appliance | Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure. 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Airway Interventions | Through study completion, an average of 1 day |
|
1 Day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group #1: Anti-snoring Appliance | Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Cough in the Post Anesthesia Care Unit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul C. Fitzgerald, RN, BSN,MS | Northwestern University | 312-695-1064 | p-fitzgerald2@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2023 | Jul 28, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000402 | Airway Obstruction |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012135 | Respiratory Sounds |
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Randomized controlled interventional trial
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| No anti -snoring device during their procedure. | Procedure | For group 2 there will be no anti snoring device used during the case. |
|
|
| Number of Instances SpO2 Value < 92% |
Number of instances the SpO2 drops below 92% during the procedure |
| Through study completion, an average of 1 day |
| 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 |
| 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 |
| Maximum SpO2 Value During the Case | Maximum SpO2 value during the case using pulse oximetry (percent saturated) | Through study completion, an average of 1 day |
| Minimum SpO2 Value During the Case | Minimum SpO2 value during the case using pulse oximetry (percent saturation) | Through study completion, an average of 1 day |
| Heart Rate Maximum | Maximum heart rate during case using standard operating room cardiac monitor | Through study completion, an average of 1 day |
| Heart Rate Minimum | Minimum heart rate during case using standard operating room cardiac monitor | Through study completion, an average of 1 day |
| Maximum Systolic Blood Pressure | Maximum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day |
| Minimum Systolic Blood Pressure | Minimum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day |
| Maximum Diastolic Blood Pressure | Maximum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day |
| Minimum Diastolic Blood Pressure | Minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day |
| Minimum Mean Blood Pressure | Mean minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day |
| Maximum Mean Blood Pressure | Maximum mean blood pressure (mmHG) using standard operating room blood pressure cuff and monitor. | Through study completion, an average of 1 day |
| Reintubation in the Post Anesthesia Care Unit | Number of participants requiring reintubation with an endotracheal tube post surgery in the Post Anesthesia Care Unit | 1 Day |
| Surgical Length of Time | Surgical length of time in hours. | 1 day |
| Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance |
Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure. No anti -snoring device during their procedure.: For group 2 there will be no anti snoring device used during the case. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Chicago, Illinois, United States | Number | participants |
|
| Height (Inches) | Mean | Standard Deviation | Inches |
|
| Weight (Kilograms) | Mean | Standard Deviation | Kilograms |
|
| Body Mass Index | Mean | Standard Deviation | (kg) / height (m)^2 |
|
| American Society of Anesthesiology Status | American Society of Anesthesiology (ASA PS Score) system used to classify a patient's physical health prior to surgery. The score, ranges from I to VI (with an added "E" for emergencies), indicates the severity of a patient's systemic disease. ASA I: Healthy patient. ASA II: Mild systemic disease. ASA III: Severe systemic disease. ASA IV: Severe systemic disease that is a constant threat to life. ASA V: Moribund patient who is not expected to survive without the operation. ASA VI: Brain Dead (donor) E: Add E if the patient requires emergency surgery. | Count of Participants | Participants |
|
| Documented Mallampati Score | Mallampati score is used in anesthesiology to assess the visibility of structures in the mouth (soft palate, uvula, faucial pillars) and predict the difficulty of intubation. A higher score is associated with a higher likelihood of difficult intubation. Class I: Soft palate, uvula, and faucial pillars are completely visible. Class II: Soft palate and uvula are visible, but the faucial pillars are partially or completely masked. Class III: Soft palate is visible, but the uvula is masked, and only the base of the uvula may be visible. Class IV: Only the hard palate is visible. | Count of Participants | Participants |
|
| Documented Obstructive Sleep Apnea | Documented sleep apnea recorded in the electronic medical record. | Count of Participants | Participants |
|
| STOP Bang Score | STOP Bang tool is used to assess the risk of obstructive sleep apnea (OSA). based on a questionnaire with eight yes/no questions, and the total score (ranging from 0 to 8) indicates the likelihood of having moderate to severe OSA. A higher score suggests a greater risk of OSA. | Mean | Standard Deviation | Score on Scale (0 low risk -8 high risk) |
|
Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure. No anti -snoring device during their procedure.: For group 2 there will be no anti snoring device used during the case. |
|
|
| 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. | Posted | Mean | Standard Deviation | mmHG | Through study completion, an average of 1 day |
|
|
|
| Secondary | Number of Instances SpO2 Value < 92% | Number of instances the SpO2 drops below 92% during the procedure | Posted | Mean | Standard Deviation | Episodes | 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. | Posted | Mean | Standard Deviation | 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. | Posted | Mean | Standard Deviation | Percent of Time | Through study completion, an average of 1 day |
|
|
|
| Secondary | Maximum SpO2 Value During the Case | Maximum SpO2 value during the case using pulse oximetry (percent saturated) | Posted | Mean | Standard Deviation | Percent | Through study completion, an average of 1 day |
|
|
|
| Secondary | Minimum SpO2 Value During the Case | Minimum SpO2 value during the case using pulse oximetry (percent saturation) | Posted | Mean | Standard Deviation | Percent | Through study completion, an average of 1 day |
|
|
|
| Secondary | Heart Rate Maximum | Maximum heart rate during case using standard operating room cardiac monitor | Posted | Mean | Standard Deviation | Heart Rate (Beats Per Minute) | Through study completion, an average of 1 day |
|
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| Secondary | Heart Rate Minimum | Minimum heart rate during case using standard operating room cardiac monitor | Posted | Mean | Standard Deviation | Heart Rate (Beats Per Minute) | Through study completion, an average of 1 day |
|
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|
| Secondary | Maximum Systolic Blood Pressure | Maximum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor. | Posted | Mean | Standard Deviation | mmHG | Through study completion, an average of 1 day |
|
|
|
| Secondary | Minimum Systolic Blood Pressure | Minimum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor. | Posted | Mean | Standard Deviation | mmHG | Through study completion, an average of 1 day |
|
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|
| Secondary | Maximum Diastolic Blood Pressure | Maximum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor. | Posted | Mean | Standard Deviation | mmHG | Through study completion, an average of 1 day |
|
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|
| Secondary | Minimum Diastolic Blood Pressure | Minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor. | Posted | Mean | Standard Deviation | mmHG | Through study completion, an average of 1 day |
|
|
|
| Secondary | Minimum Mean Blood Pressure | Mean minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor. | Posted | Mean | Standard Deviation | mmHG | Through study completion, an average of 1 day |
|
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| Secondary | Maximum Mean Blood Pressure | Maximum mean blood pressure (mmHG) using standard operating room blood pressure cuff and monitor. | Posted | Mean | Standard Deviation | mmHG | Through study completion, an average of 1 day |
|
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| Secondary | Reintubation in the Post Anesthesia Care Unit | Number of participants requiring reintubation with an endotracheal tube post surgery in the Post Anesthesia Care Unit | Posted | Count of Participants | Participants | 1 Day |
|
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|
| Secondary | Surgical Length of Time | Surgical length of time in hours. | Posted | Mean | Standard Deviation | Hours | 1 day |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance | Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure. No anti -snoring device during their procedure.: For group 2 there will be no anti snoring device used during the case. | 0 | 13 | 0 | 13 | 0 | 13 |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Bronchospasm in the Post Anesthesia Care Unit |
|
| Regurgitation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Regurgitation event in Post Anesthesia Care Unit |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Aspiration of gastric contents into the airway in the PACU |
|
| Case converted to general anesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Surgical case changed to general anesthesia during the procedure due to respiratory deficiency. |
|
| Rapid Response Team Alerted | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Rapid Response Team alerted for cardiac and or respiratory failure |
|
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| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |