Airway Management, Airway Obstruction Upper, Mask Ventilation
Conditions
Keywords
Morbid obesity, Obstructive sleep apnea, Mask ventilation, Upper airway obstruction
Brief summary
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.
Detailed description
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.
Interventions
DEVICEArticulated 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.
DEVICEGuedel 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.
Sponsors
Ron Abrons
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Individuals demonstrating 2 or greater predictors of difficult mask ventilation (as listed below) who are scheduled for elective surgery with general anesthesia and asleep mask ventilation/orotracheal intubation utilizing long-acting neuromuscular blockade. * Predictors of difficult mask ventilation i) Age \> 55 years ii) BMI \> 30kg/m2 iii) Beard iv) Lack of teeth v) History of snoring
Exclusion criteria
* Documented history of impossible mask ventilation * Planned omission of mask ventilation ('rapid-sequence induction,' etc.) * Planned omission of long-acting paralytics * Need for awake airway management * Need for emergent airway protection * Presence of oropharyngeal anatomic abnormalities * Distance from the maxillary incisors to the angle of the mandible \<11cm * \<18 years of age * Known pregnant state * Current incarceration * Refusal to be involved in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expiratory Tidal Volume (Breaths 6-10) | Measured immediately after placement of each oral airway; an average of 2-5 minutes. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Tidal Volume (Breaths 6-10) | Measured immediately after placement of each oral airway; an average of 2-5 minutes. | 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 |
| Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First | Measured immediately after removal of first oral airway and before placing the second oral airway | 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.. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 28 |
| Total | 56 |
Baseline characteristics
| Characteristic | Guedel Oral Airway Placed First | Articulated Oral Airway Placed First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 13 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 15 Participants | 34 Participants |
| BMI | 34.8 kg/m^2 | 36.1 kg/m^2 | 35.4 kg/m^2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
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
Time frame: Measured immediately after placement of each oral airway; an average of 2-5 minutes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Guedel Oral Airway | Expiratory Tidal Volume (Breaths 6-10) | First intervention-breaths 6 through 10 | 4.46 ml/kg |
| Guedel Oral Airway | Expiratory Tidal Volume (Breaths 6-10) | Second intervention-breaths 6 through 10 | 3.12 ml/kg |
| Articulated Oral Airway | Expiratory Tidal Volume (Breaths 6-10) | First intervention-breaths 6 through 10 | 3.21 ml/kg |
| Articulated Oral Airway | Expiratory Tidal Volume (Breaths 6-10) | Second intervention-breaths 6 through 10 | 3.48 ml/kg |
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..
Time frame: Measured immediately after removal of first oral airway and before placing the second oral airway
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Guedel Oral Airway | Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First | 3 Devices with blood |
| Articulated Oral Airway | Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First | 0 Devices with blood |
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
Time frame: Measured immediately after placement of each oral airway; an average of 2-5 minutes.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Guedel Oral Airway | Inspiratory Tidal Volume (Breaths 6-10) | First intervention-breaths 6 though 10 | 6.37 ml/kg |
| Guedel Oral Airway | Inspiratory Tidal Volume (Breaths 6-10) | Second intervention-breaths 6 through 10 | 5.83 ml/kg |
| Articulated Oral Airway | Inspiratory Tidal Volume (Breaths 6-10) | First intervention-breaths 6 though 10 | 5.7 ml/kg |
| Articulated Oral Airway | Inspiratory Tidal Volume (Breaths 6-10) | Second intervention-breaths 6 through 10 | 6.72 ml/kg |