New Airway for Awake Intubation (McKay Airway)

NCT04051424 | Completed

• 1 other identifier: BIO 17 - 202
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Ease of use.

  Ordinal scale comparison with standard bite block for ease of obtaining a bronchoscopic view of vocal cords or epiglottis (scale of 1 to 5 - see data sheets below).

  5 minutes

• Time to visualize cords.

  Time in seconds from starting bronchoscope insertion to cord visualization.

  5 minutes

Secondary Outcomes (1)

• Usefulness.

  5 minutes

Study Arms (3)

ConMed bite block

ACTIVE COMPARATOR

Standard bite block (Conmed Bite Block; Conmed Corp., Utica NY, USA)

Device: McKay airway; Device: Williams Airway

Williams Airway

ACTIVE COMPARATOR

Williams Airway Intubator (Williams Airway Intubator Ltd, Calgary, Canada)

Device: ConMed bite block; Device: McKay airway

McKay airway

EXPERIMENTAL

A new device that enables maintenance of jaw thrust. (US patent application 16/098,530)

Device: ConMed bite block; Device: Williams Airway

Interventions

ConMed bite block DEVICE

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

McKay airway; Williams Airway

McKay airway DEVICE

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

ConMed bite block; Williams Airway

Williams Airway DEVICE

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

ConMed bite block; McKay airway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are of two kinds, first, anesthesiologists and anesthesia residents who will perform partial bronchoscopy, and
• secondly, healthy volunteers. Healthy volunteers will be recruited from hospital staff, residents and students at Royal University Hospital.

You may not qualify if:

• Excepted anesthesiologists and residents will be those who do not wish to participate in the study.
• Excepted volunteers will be those who do not wish to participate in the study and those with a lidocaine allergy.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Saskatoon Health Region, 410 22nd Street East

Saskatoon, Saskatchewan, S7K 5T6, Canada

Location

Study Officials

• William P McKay, MD

  Professor Emeritus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Design: The proposed experiment is a randomized clinical crossover (repeated measures) trial of three oral bite-block devices with device order randomized and blinded prior to recruitment.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 9, 2019
• Study Start: April 4, 2018
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 2017 - indefinitely
• Access Criteria: Interested applicant

Locations

CA (1)