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New Airway for Awake Intubation (McKay Airway)

NCT04051424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2019-08-09

No results posted yet for this study

Summary

When endotracheal intubation is known or predicted to be difficult, patients are intubated awake using a flexible bronchoscope (awake fibre-optic intubation: AFI) so that they can protect their airway with normal upper airway muscle activity until the endotracheal tube (ETT) is safely in place. New bite blocks have been invented for bag mask ventilation but are not suitable for AFI.1 A newly invented airway device, the McKay airway, may provide a better solution for AFI by enabling jaw thrust, a condition where the upper airway is opened more as the jaw is protruded forward. It may also be more comfortable for awake users. A study is proposed to assess the functionality of the device for this purpose.

To protect the bronchoscope, a bite block is used during AFI to protect the very delicate glass fibres from damage from inadvertent biting by the patient. Currently used bite blocks protect the scope, but do not position the jaw optimally for scoping. The proposed device is an attempt to improve upon current bite blocks by both protecting the bronchoscope and positioning the jaw optimally.

Hypothesis: Residents in training in the Division of Respirology have limited experience in fibre-optic bronchoscopy and perform it under the direct supervision of an expert. Null hypothesis: the time to visualization of vocal cords with a fibre-optic bronchoscope by residents learning in the Division of Respirology will be no different with the McKay airway than with the conventional bite block or Williams Airway.

Conditions

  • Healthy

Interventions

DEVICE

ConMed bite block

Investigator will fit ConMed bite block in patient's mouth and bronchoscopist will try to visualize the vocal cords.

DEVICE

McKay airway

Investigator will fit McKay airway in patient's mouth and bronchoscopist will try to visualize the vocal cords.

DEVICE

Williams Airway

Investigator will fit Williams Airway in patient's mouth and bronchoscopist will try to visualize the vocal cords.

Sponsors & Collaborators

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • William P McKay, MD · Professor Emeritus

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2019-07-25
Completion
2019-07-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04051424 on ClinicalTrials.gov