- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03144089
The Articulated Oral Airway as an Aid to Mask Ventilation
The Articulated Oral Airway as an Aid to Mask Ventilation, a Prospective Interventional, Non-Inferiority Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- The University of Iowa Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Measured immediately after placement of each oral airway; an average of 2-5 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inspiratory Tidal Volume (Breaths 6-10)
Time Frame: 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 |
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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ron O Abrons, MD, The University of Iowa Hospitals and Clinics
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201704829
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Airway Management
-
NHS TaysideTerminated
-
Insel Gruppe AG, University Hospital BernThe Hospital for Sick Children; Children's Hospital of Philadelphia; Charite... and other collaboratorsRecruitingAirway ManagementSwitzerland, Canada, Germany
-
Peking Union Medical College HospitalNot yet recruiting
-
Tufts Medical CenterActive, not recruitingAirway ManagementUnited States
-
Joint Authority for Päijät-Häme Social and Health...University of TurkuCompleted
-
Universitätsklinikum Hamburg-EppendorfCompleted
-
Nordsjaellands HospitalCompleted
-
Indonesia UniversityCompleted
-
Eye & ENT Hospital of Fudan UniversityCompleted
-
Guy's and St Thomas' NHS Foundation TrustCompleted
Clinical Trials on Guedel oral airway (active comparator)
-
University of SaskatchewanUnknownAnesthesia, GeneralCanada
-
University Hospital, Basel, SwitzerlandUniversity Children's Hospital BaselWithdrawn
-
University of VermontUnknownAirway Obstruction | Respiratory ComplicationUnited States
-
Rajiv Gandhi Cancer Institute & Research Center...CompletedObjective Vocal Cord Movement Assessment by C-Mac Videolaryngoscope Vs Airway Ultrasound in Ca ThyroidIndia
-
Aga Khan UniversityRecruiting
-
NImmune BiopharmaWithdrawn
-
TiumBio Co., Ltd.RecruitingEndometriosisCzechia, Italy, Russian Federation, Poland, Ukraine
-
3MCompleted
-
Yonsei UniversityCompletedAdult Patients Undergoing Surgery That Requires General AnesthesiaKorea, Republic of
-
Eisai Inc.CompletedAlzheimer's DiseaseUnited States