The Articulated Oral Airway as an Aid to Mask Ventilation

• Sponsor: Ron Abrons (Other)
• Overall Status: Completed
• CT.gov ID: NCT03144089
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.5
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mask Ventilation; Airway Obstruction Upper; Airway Management	Device: Articulated Oral Airway; Device: Guedel oral airway (active comparator)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.
• Masking: Quadruple (Participant, Care Provider, 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.
• Primary Purpose: Treatment
• Official Title: The Articulated Oral Airway as an Aid to Mask Ventilation, a Prospective Interventional, Non-Inferiority Study
• Actual Study Start Date: Jul 11, 2017
• Actual Primary Completion Date: Feb 25, 2019
• Actual Study Completion Date: Feb 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Guedel oral airway 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.	Device: 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.
Experimental: Articulated Oral Airway 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.	Device: 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.; Other Names: AOA Abrons AOA Abrons Articulated Oral Airway

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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..

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Iowa Hospital	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• Ron Abrons

Investigators

• Principal Investigator: Ron O Abrons, MD, The University of Iowa Hospitals and Clinics

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 16, 2021
• Informed Consent Form - May 16, 2021

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Ron Abrons, Assistant Professor of Anesthesiology, University of Iowa
• ClinicalTrials.gov Identifier: NCT03144089
• Other Study ID Numbers: 201704829
• First Posted: May 8, 2017
• Last Update Posted: Jul 23, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Ron Abrons, Assistant Professor of Anesthesiology, University of Iowa: Morbid obesity; Obstructive sleep apnea; Mask ventilation; Upper airway obstruction
• Additional relevant MeSH terms: Airway Obstruction

Study Results

Participant Flow

Arm/Group Title	Guedel Oral Airway Placed First	Articulated Oral Airway Placed First
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	28	28
COMPLETED	28	28
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Guedel Oral Airway Placed First	Articulated Oral Airway Placed First	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	28	28	56
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 67.9%	15 53.6%	34 60.7%
>=65 years	9 32.1%	13 46.4%	22 39.3%
Sex: Female, Male (Count of Participants)
Female	12 42.9%	9 32.1%	21 37.5%
Male	16 57.1%	19 67.9%	35 62.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	28 100%	28 100%	56 100%
BMI (kg/m^2) [Median (Full Range) ]
Median (Full Range) [kg/m^2]	34.8	36.1	35.4

Outcome Measures

1. Primary Outcome

Title	Expiratory Tidal Volume (Breaths 6-10)
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Guedel Oral Airway	Articulated Oral Airway
Arm/Group Description	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.	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.
Measure Participants	28	28
First intervention-breaths 6 through 10	4.46	3.21
Second intervention-breaths 6 through 10	3.12	3.48

2. Secondary Outcome

Title	Inspiratory Tidal Volume (Breaths 6-10)
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Guedel Oral Airway	Articulated Oral Airway
Arm/Group Description	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.	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.
Measure Participants	28	28
First intervention-breaths 6 though 10	6.37	5.7
Second intervention-breaths 6 through 10	5.83	6.72

3. Secondary Outcome

Title	Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Guedel Oral Airway Placed First	Articulated Oral Airway Placed First
Arm/Group Description	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.	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.
Measure Participants	28	28
Number [Devices with blood]	3	0

Adverse Events

Time Frame	Day of surgical procedure.
Arm/Group Title	Guedel Oral Airway		Articulated Oral Airway
Arm/Group Description	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.		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.
All Cause Mortality
	Guedel Oral Airway		Articulated Oral Airway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)
Serious Adverse Events
	Guedel Oral Airway		Articulated Oral Airway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Guedel Oral Airway		Articulated Oral Airway
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/56 (0%)		0/56 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.