Videolaryngoscopy in Patients With Cervical Spine Immobilisation

September 28, 2015 updated by: Lynsey Foulds, NHS Tayside

A Randomised Crossover Trial Comparing the McGrath Series 5 Videolaryngoscope With the Macintosh Laryngoscope in Patients With Cervical Spine Immobilisation

Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. The relatively short radius of the blade curvature combined with the internal arrangement of optimal components means that the glottis can be seen without the need for alignment of the oral, pharyngeal and tracheal axes.

The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view of the larynx in patients with limited neck movements, making intubation quicker, easier and possibly safer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

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

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective procedure requiring tracheal intubation
  • Over 16 years of age

Exclusion Criteria:

  • Emergency procedure
  • Less than 16 years of age
  • Unable to consent
  • Symptomatic gastro-oesophageal reflux disease
  • Evidence of raised intracranial pressure
  • Known pharyngeal pathology

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: McGrath Series 5
Videolaryngoscope used to perform indirect (video) laryngoscopy and tracheal intubation
Device: Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated.
Active Comparator: Macintosh
Laryngoscope used to perform direct laryngoscopy and tracheal intubation
Device: Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cormack and Lehane laryngoscopy grade
Time Frame: 5 minutes
5 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to intubation
Time Frame: 5 minutes
5 minutes
Rate of successful tracheal intubation
Time Frame: 5 minutes
5 minutes
Incidence of complications
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

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

Sponsor

NHS Tayside

Investigators

  • Principal Investigator: Lynsey T Foulds, MBChB, NHS Tayside

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

August 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 25, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2008AN01

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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