Mask VentilationNCT03144089
The Articulated Oral Airway as an Aid to Mask Ventilation
A study testing Articulated Oral Airway and Guedel oral airway (active comparator) in people with Mask Ventilation and Airway Obstruction Upper, run by Ron Abrons at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Mask Ventilation, Airway Obstruction Upper, Airway Management
- What is being tested?
- Articulated Oral Airway and Guedel oral airway (active comparator)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2017to 25 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Iowa Hospital
Iowa City, Iowa, 52242
About this study
Official title: The Articulated Oral Airway as an Aid to Mask Ventilation, a Prospective Interventional, Non-Inferiority Study
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.
Read the 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.
- Being tested
- Articulated Oral Airway, Guedel oral airway (active comparator)
- Keywords
- Morbid obesity, Obstructive sleep apnea, Mask ventilation, Upper airway obstruction
- Medical subject headings
- Obesity, Morbid, Sleep Apnea, Obstructive, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articulated Oral AirwayDevice
Also called AOA, Abrons AOA, Abrons 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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Guedel oral airway (active comparator) |
| 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. Receives: Device: Articulated Oral Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured immediately after placement of each oral airway; an average of 2-5 minutes.
Secondary outcomes (2)
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
Measured: 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: Measured immediately after removal of first oral airway and before placing the second oral airway
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start11 Jul 2017
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mask VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ron Abrons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ron Abrons, University of Iowa
- Investigators
- Ron O Abrons, MD, Principal investigator, The University of Iowa Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144089
- Sponsor's protocol ID
- 201704829
- Status last verified
- Jul 2021
- First submitted
- 17 Apr 2017
- Last updated
- 23 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 11259887Langeron 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.
PubMed 10781266Kheterpal 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.
PubMed 17065880Kheterpal 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.
PubMed 19293691Abrons 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.
PubMed 33781212
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Articulated Oral Airway as an Aid to Mask Ventilation, a Prospective Interventional, Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT03144089
- Acronym / sponsor ID
- 201704829
- Keywords
- Morbid obesity, Obstructive sleep apnea, Mask ventilation, Upper airway obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Ron AbronsUniversity, hospital or other
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Posted 23 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, crossover design. All patients will receive both interventions during a single anesthetic, with the order of intervention being randomized.
| Arm | Type | Receives |
|---|---|---|
| Guedel oral airway | Active comparator | Device: 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. |
| Articulated Oral Airway | Experimental | Device: Articulated Oral AirwayEach 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Articulated Oral AirwayAlso: AOA, Abrons AOA, Abrons Articulated Oral AirwayThe 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. | Device | Articulated Oral Airway |
| 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. | Device | Guedel oral airway |
Primary outcome
Expiratory Tidal Volume (Breaths 6-10)
Time frame: 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
2 secondary outcomes
Inspiratory Tidal Volume (Breaths 6-10)
Time frame: 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
Time frame: Measured immediately after removal of first oral airway and before placing the second oral airway
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11259887Koga 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.
- Background: PubMed 10781266Langeron 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.
- Background: PubMed 17065880Kheterpal 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.
- Background: PubMed 19293691Kheterpal 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.
- Derived from this study: PubMed 33781212Abrons 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron O Abrons, MD principal investigator
The University of Iowa Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Articulated Oral Airway and Guedel oral airway (active comparator) in people with Mask Ventilation and Airway Obstruction Upper, run by Ron Abrons at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expiratory Tidal Volume (Breaths 6-10) (time frame: Measured immediately after placement of each oral airway; an average of 2-5 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144089, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.