Trial Outcomes & Findings for The Articulated Oral Airway as an Aid to Mask Ventilation (NCT NCT03144089)
NCT ID: NCT03144089
Last Updated: 2021-07-23
Results Overview
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
COMPLETED
NA
58 participants
Measured immediately after placement of each oral airway; an average of 2-5 minutes.
2021-07-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Guedel Oral Airway Placed First
n=28 Participants
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.
|
Articulated Oral Airway Placed First
n=28 Participants
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.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=56 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=28 Participants
|
15 Participants
n=28 Participants
|
34 Participants
n=56 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=28 Participants
|
13 Participants
n=28 Participants
|
22 Participants
n=56 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=28 Participants
|
9 Participants
n=28 Participants
|
21 Participants
n=56 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=28 Participants
|
19 Participants
n=28 Participants
|
35 Participants
n=56 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
28 participants
n=28 Participants
|
56 participants
n=56 Participants
|
|
BMI
|
34.8 kg/m^2
n=28 Participants
|
36.1 kg/m^2
n=28 Participants
|
35.4 kg/m^2
n=56 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Guedel Oral Airway
n=28 Participants
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.
|
Articulated Oral Airway
n=28 Participants
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.
|
|---|---|---|
|
Expiratory Tidal Volume (Breaths 6-10)
First intervention-breaths 6 through 10
|
4.46 ml/kg
Interval 3.86 to 5.07
|
3.21 ml/kg
Interval 2.62 to 3.79
|
|
Expiratory Tidal Volume (Breaths 6-10)
Second intervention-breaths 6 through 10
|
3.12 ml/kg
Interval 2.54 to 3.7
|
3.48 ml/kg
Interval 2.87 to 4.08
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Guedel Oral Airway
n=28 Participants
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.
|
Articulated Oral Airway
n=28 Participants
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.
|
|---|---|---|
|
Inspiratory Tidal Volume (Breaths 6-10)
First intervention-breaths 6 though 10
|
6.37 ml/kg
Interval 5.35 to 7.4
|
5.7 ml/kg
Interval 4.71 to 6.68
|
|
Inspiratory Tidal Volume (Breaths 6-10)
Second intervention-breaths 6 through 10
|
5.83 ml/kg
Interval 4.84 to 6.82
|
6.72 ml/kg
Interval 5.7 to 7.75
|
SECONDARY outcome
Timeframe: Measured immediately after removal of first oral airway and before placing the second oral airwayAfter 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..
Outcome measures
| Measure |
Guedel Oral Airway
n=28 Participants
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.
|
Articulated Oral Airway
n=28 Participants
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.
|
|---|---|---|
|
Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First
|
3 Devices with blood
|
0 Devices with blood
|
Adverse Events
Guedel Oral Airway
Articulated Oral Airway
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ron Abrons, MD
University of Iowa Hospitals and Clinics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place