Optimal Head and Neck Position During Videolaryngoscopy

Optimal Head and Neck Position for Intubation During Videolaryngoscopy: Comparison Between "Sniffing" and Neutral Position Using Channelled and Non-channelled Videolaryngoscopes

Optimal patient head and neck position when performing videolaryngoscopy for endotracheal intubation has not yet been established.The investigators aim to assess the effect of two different positions on the laryngeal view obtained and success of tracheal intubation during videolaryngoscopy with two commercially available and well established videolaryngoscopes.

Study Overview

Detailed Description

The optimum patient head and neck position for direct laryngoscopy (when the anaesthetist views the larynx with a curved metallic blade before passing a tube for ventilation of the lungs) is traditionally considered to be the "sniffing the morning air" (neck flexion and head extension) position. This has been questioned previously as there is no randomized controlled study to date to explore this statement. The patient should be optimally positioned prior to induction of anaesthesia, especially because in the event of an unexpected difficult intubation, the Difficult Airway Society guidelines suggest the use of an alternative laryngoscope. In current clinical practice a videolaryngoscope (a curved blade with a camera attached to it that allows the anaesthetist to see around corners) has been used as an alternative laryngoscope. To the best of our knowledge, the ideal patient position for videolaryngoscopy has not yet been described. The intubation time and rate of success at intubation using a C-Mac D-Blade videolaryngoscope was previously assessed by Serocki et al, but only in the sniffing position. It is possible that adopting a different position when using the C-Mac D- Blade might result in a superior view of the larynx. Furthermore, the optimal patient position has not yet been assessed for intubation with the King Vision videolaryngoscope.

This key information could gain precious seconds in a difficult airway scenario (when securing the airway with a tube for ventilation proves difficult) and has obvious implications for patient management. The answer to this question could also help the anaesthetists take informed decisions when using videolaryngoscopy to intubate the trachea in elective settings. The investigators aim to assess the effect of two different positions on the laryngeal view obtained during videolaryngoscopy with two commercially available and well established videolaryngoscopes to try and answer this question.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry & Warwickshire NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients aged 18 and above, presenting for elective surgical procedure and requiring tracheal intubation will be invited to take part in the study.

Exclusion Criteria:

  • Patients who are refusing to take part, below 18 years of age, pregnant women, American society of anaesthesiologists' class 4 and above, those requiring rapid sequence indication, super morbidly obese (BMI >50) and those patients requiring awake fibreoptic intubation will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: C-Mac D-Blade Neutral Position
C-Mac D-Blade videolaryngoscope with patients head and neck in neutral position.
Using C-Mac D-Blade Videolaryngoscope patients will be positioned the neutral Head and Neck Position
Using C-Mac D-Blade Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position
Active Comparator: C-Mac D-Blade Sniffing Position
C-Mac D-Blade videolaryngoscope with patients head and neck in sniffing position.
Using C-Mac D-Blade Videolaryngoscope patients will be positioned the neutral Head and Neck Position
Using C-Mac D-Blade Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position
Active Comparator: King Vision Neutral Position
King Vision videolaryngoscope with patients head and neck in neutral position.
Using the King Vision Videolaryngoscope patients will be positioned in the neutral Head and Neck Position
Using the King Vision Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position
Active Comparator: King Vision Sniffing Position
King Vision videolaryngoscope with patients head and neck in sniffing position.
Using the King Vision Videolaryngoscope patients will be positioned in the neutral Head and Neck Position
Using the King Vision Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal Head and Neck Position during Videolaryngoscopy
Time Frame: 6 months
This will be assessed using a Difficult Intubation Scale Score for each of the 2 videolaryngoscopes used in the study, which will be assessed in both neutral and sniffing positions.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Laryngoscopy Time
Time Frame: Less than 1 minute
From when the laryngoscope enters the mouth until achieving the best view of the larynx.
Less than 1 minute
Intubation Time
Time Frame: Less than 1 minute
from entering the mouth with the videolaryngoscope until endotracheal tube is inserted in the wind-pipe and the capnography trace is first visible on the screen.
Less than 1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cyprian Mendonca, consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2015

Primary Completion (Actual)

April 27, 2017

Study Completion (Actual)

April 27, 2017

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 178075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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