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The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The investigators hypothesize that, in patients with predictors for difficult mask ventilation, the AOA will be non-inferior to the Geudel oral airway in terms of expired tidal volumes.
Difficult mask ventilation (MV) is common in the obese population and can result in patient morbidity and mortality. The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for MV. The investigators hypothesize that, while using the same ventilatory pressure in neuromuscularly blocked patients with predictors for difficult mask ventilation, MV with an AOA will not result in smaller expired tidal volumes than MV with a similarly sized Guedel oral airway (GDA). In other words, the AOA will be non-inferior to the GDA in terms of expired tidal volumes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guedel oral airway | Active Comparator | Each participant in the study will have both devices (GOA or AOA). The participants reported in this arm were randomized to receive the Guedel oral airway first and measurements were taken during breaths 6 through 10. After its removal the Articulated Oral Airway was inserted and measurements were repeated again during breaths 6 through 10. |
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| Articulated Oral Airway | Experimental | Each participant in the study will have both devices (GOA or AOA). The participants reported in this arm were randomized to receive the Articulated oral airway first and measurements were taken during breaths 6 through 10. After its removal the Guedel Oral Airway was inserted and measurements were repeated again during breaths 6 through 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Articulated Oral Airway | Device | The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation. |
| Measure | Description | Time Frame |
|---|---|---|
| Expiratory Tidal Volume (Breaths 6-10) | Measured expiratory tidal volume (from video of anesthesia monitor). Each participant had measurements collected during breaths number 6-10 after the insertion of each oral airway (GOA or AOA) with the order of first treatment randomized. The average expiratory tidal volumes reported were weight standardized per kilogram of participant's body weight, meaning the expiratory measurements were divided by the participant's weight (kg). A total of 56 patients were enrolled and randomized--28 received the Guedel Oral Airway first and 28 received the Articulated Oral Airway first. The average expiratory values are reported as outlined in table below: Guedel inserted first AOA inserted first Guedel inserted second AOA inserted second | Measured immediately after placement of each oral airway; an average of 2-5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory Tidal Volume (Breaths 6-10) | Measured inspiratory tidal volume (from video of anesthesia monitor). Each participant had measurements collected during breaths number 6-10 after the insertion of each oral airway (GOA or AOA) with the order of first treatment randomized. The average inspiratory tidal volumes reported were weight-standardized per kilogram of participant's body weight, meaning the inspiratory measurements were divided by the participant's weight (kg). A total of 56 patients were enrolled and randomized--28 received the Guedel Oral Airway first and 28 received the Articulated Oral Airway first. The average inspiratory values are reported as outlined in table below: Guedel inserted first AOA inserted first Guedel inserted second AOA inserted second |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron O Abrons, MD | The University of Iowa Hospitals and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Iowa Hospital | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11259887 | Background | Koga K, Sata T, Kaku M, Takamoto K, Shigematsu A. Comparison of no airway device, the Guedel-type airway and the Cuffed Oropharyngeal Airway with mask ventilation during manual in-line stabilization. J Clin Anesth. 2001 Feb;13(1):6-10. doi: 10.1016/s0952-8180(00)00228-2. | |
| 10781266 | Background | Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Guedel Oral Airway Placed First | This group is randomized to receive the Guedel oral airway first and the Articulated Oral Airway second Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation. Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation. |
| FG001 | Articulated Oral Airway Placed First | This group is randomized to receive the Articulated Oral Airway first and the Guedel oral airway second Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation. Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Guedel Oral Airway Placed First | This group is randomized to receive the Guedel oral airway first and the Articulated Oral Airway second Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation. Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Expiratory Tidal Volume (Breaths 6-10) | Measured expiratory tidal volume (from video of anesthesia monitor). Each participant had measurements collected during breaths number 6-10 after the insertion of each oral airway (GOA or AOA) with the order of first treatment randomized. The average expiratory tidal volumes reported were weight standardized per kilogram of participant's body weight, meaning the expiratory measurements were divided by the participant's weight (kg). A total of 56 patients were enrolled and randomized--28 received the Guedel Oral Airway first and 28 received the Articulated Oral Airway first. The average expiratory values are reported as outlined in table below: Guedel inserted first AOA inserted first Guedel inserted second AOA inserted second | Posted | Mean | 95% Confidence Interval | ml/kg | Measured immediately after placement of each oral airway; an average of 2-5 minutes. |
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Day of surgical procedure.
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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 | Guedel Oral Airway | This group is randomized to receive the Guedel oral airway first and data recorded. The airway was removed and followed by insertion of the Articulated Oral Airway second and data recorded. Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation. Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron Abrons, MD | University of Iowa Hospitals and Clinics | (319) 353-8061 | ron-abrons@uiowa.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 | May 16, 2021 | Jun 16, 2021 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 16, 2021 | Jun 16, 2021 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D020181 | Sleep Apnea, Obstructive |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.
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Anesthesia facemasks will be opacified so that the clinical provider will be blinded to which oral airway (Guedel vs AOA) is being used and in what order. The patient will be anesthetized and thus blinded. The Investigator and Outcomes Assessor will only see video of the data on the anesthesia monitor (not the patient/device/etc) and will thus be blinded. The only individuals who will not be blinded are the Research Assistants who will not be involved in data analysis.
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| Guedel oral airway (active comparator) | Device | The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation. |
|
| Measured immediately after placement of each oral airway; an average of 2-5 minutes. |
| Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First | After the first oral airway device was removed, it was visually inspected for the presence of blood and is reported as the number of subjects where blood was visualized on the initial airway device.. | Measured immediately after removal of first oral airway and before placing the second oral airway |
| 17065880 | Background | Kheterpal S, Han R, Tremper KK, Shanks A, Tait AR, O'Reilly M, Ludwig TA. Incidence and predictors of difficult and impossible mask ventilation. Anesthesiology. 2006 Nov;105(5):885-91. doi: 10.1097/00000542-200611000-00007. |
| 19293691 | Background | Kheterpal S, Martin L, Shanks AM, Tremper KK. Prediction and outcomes of impossible mask ventilation: a review of 50,000 anesthetics. Anesthesiology. 2009 Apr;110(4):891-7. doi: 10.1097/ALN.0b013e31819b5b87. |
| 33781212 | Derived | Abrons RO, Ten Eyck P, Sheffield ID. The Articulated Oral Airway as an aid to mask ventilation: a prospective, randomized, interventional, non-inferiority study. BMC Anesthesiol. 2021 Mar 29;21(1):94. doi: 10.1186/s12871-021-01315-8. |
| BG001 | Articulated Oral Airway Placed First | This group is randomized to receive the Articulated Oral Airway first and the Guedel oral airway second Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation. Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| BMI | Median | Full Range | kg/m^2 |
|
| OG001 | Articulated Oral Airway | This group is randomized to receive the Articulated Oral Airway first and the Guedel oral airway second Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation. Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation. |
|
|
| Secondary | Inspiratory Tidal Volume (Breaths 6-10) | Measured inspiratory tidal volume (from video of anesthesia monitor). Each participant had measurements collected during breaths number 6-10 after the insertion of each oral airway (GOA or AOA) with the order of first treatment randomized. The average inspiratory tidal volumes reported were weight-standardized per kilogram of participant's body weight, meaning the inspiratory measurements were divided by the participant's weight (kg). A total of 56 patients were enrolled and randomized--28 received the Guedel Oral Airway first and 28 received the Articulated Oral Airway first. The average inspiratory values are reported as outlined in table below: Guedel inserted first AOA inserted first Guedel inserted second AOA inserted second | Posted | Mean | 95% Confidence Interval | ml/kg | Measured immediately after placement of each oral airway; an average of 2-5 minutes. |
|
|
|
| Secondary | Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First | After the first oral airway device was removed, it was visually inspected for the presence of blood and is reported as the number of subjects where blood was visualized on the initial airway device.. | Posted | Number | Devices with blood | Measured immediately after removal of first oral airway and before placing the second oral airway |
|
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| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Articulated Oral Airway | This group is randomized to receive the Articulated Oral Airway first and data recorded. The airway was removed and followed by insertion the Guedel oral airway second and data recorded. Articulated Oral Airway: The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation. Guedel oral airway (active comparator): The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation. | 0 | 56 | 0 | 56 | 0 | 56 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012131 | Respiratory Insufficiency |