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NCT03144089

The Articulated Oral Airway as an Aid to Mask Ventilation

Completed NA Results posted Last updated 23 July 2021
What this trial tests

NA trial testing Articulated Oral Airway in Mask Ventilation in 58 participants. Completed in 25 February 2019.

Timeline
11 July 2017
Primary endpoint
25 February 2019
25 February 2019

Quick facts

Lead sponsorRon Abrons
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment58
Start date11 July 2017
Primary completion25 February 2019
Estimated completion25 February 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Ron Abrons

Who can join

Adults 18 to 99, any sex, with Mask Ventilation or Airway Obstruction Upper. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Expiratory Tidal Volume (Breaths 6-10) Primary · 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 expirat

First intervention-breaths 6 through 10
GroupValue95% CI
Guedel Oral Airway4.463.86 – 5.07
Articulated Oral Airway3.212.62 – 3.79
Second intervention-breaths 6 through 10
GroupValue95% CI
Guedel Oral Airway3.122.54 – 3.70
Articulated Oral Airway3.482.87 – 4.08
Inspiratory Tidal Volume (Breaths 6-10) Secondary · 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 insp

First intervention-breaths 6 though 10
GroupValue95% CI
Guedel Oral Airway6.375.35 – 7.40
Articulated Oral Airway5.74.71 – 6.68
Second intervention-breaths 6 through 10
GroupValue95% CI
Guedel Oral Airway5.834.84 – 6.82
Articulated Oral Airway6.725.70 – 7.75
Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First Secondary · 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..

GroupValue95% CI
Guedel Oral Airway Placed First3
Articulated Oral Airway Placed First0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Articulated Oral Airway as an aid to mask ventilation: a prospective, randomized, interventional, non-inferiority study.
    Abrons RO, Ten Eyck P, Sheffield ID. · · 2021 · PMID 33781212 · DOI 10.1186/s12871-021-01315-8

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03144089.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing