Optimal Head and Neck Position During Videolaryngoscopy

August 6, 2018 updated by: University Hospitals Coventry and Warwickshire NHS Trust

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United Kingdom
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: C-Mac D-Blade Neutral Position
C-Mac D-Blade videolaryngoscope with patients head and neck in neutral position.
Other: C-Mac D-Blade Videolaryngoscope
Using C-Mac D-Blade Videolaryngoscope patients will be positioned the neutral Head and Neck Position
Other: C-Mac D-Blade Videolaryngoscope
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.
Other: C-Mac D-Blade Videolaryngoscope
Using C-Mac D-Blade Videolaryngoscope patients will be positioned the neutral Head and Neck Position
Other: C-Mac D-Blade Videolaryngoscope
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.
Other: King Vision Videolaryngoscope
Using the King Vision Videolaryngoscope patients will be positioned in the neutral Head and Neck Position
Other: King Vision Videolaryngoscope
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.
Other: King Vision Videolaryngoscope
Using the King Vision Videolaryngoscope patients will be positioned in the neutral Head and Neck Position
Other: King Vision Videolaryngoscope
Using the King Vision Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospitals Coventry and Warwickshire NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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