Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope

July 29, 2011 updated by: NHS Grampian

The simplicity of use and intuitive function of the McGrath video-laryngoscope suggests it may have a bigger role than as a back-up to conventional direct laryngoscopy and could possibly be the first-line laryngoscope for situations where difficult intubations are more likely or more hazardous. The incidence of difficult or failed intubation for an individual anaesthetist is related to their experience, decreasing as experience increases. The purpose of this trial is to evaluate the McGrath laryngoscope when used by relatively inexperienced anaesthetists, who are those most likely to encounter difficulties.

The null hypotheses to be tested is that there is no difference between the Macintosh and McGrath laryngoscope in terms of ease and success in intubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • United Kingdom
    • UK
      • Aberdeen, UK, United Kingdom, AB25 2ZN
        • Aberdeen Royal Hospitals, NHS Grampian

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (18 years and over) scheduled for elective surgery whose anaesthetic plan would normally include oral intubation using a Macintosh laryngoscope blade after induction of general anaesthesia and who have given valid informed consent.

Exclusion Criteria:

  • Patients requiring special techniques for intubation such as rapid sequence induction
  • Adults who have learning difficulties
  • Are unconscious or very severely ill
  • Have a terminal illness; are in an emergency situation
  • Have a mental illness
  • Have dementia
  • Prisoners
  • Those who could be considered to have a particularly dependent relationship with the investigator and other vulnerable groups.

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: Intubation c McGrath videolaryngoscope
Tracheal Intubation using McGrath video-laryngoscope
Device: McGrath
Tracheal intubation, using Mcgrath video-laryngoscope
Other Names:
  • Aircraft Medical McGrath Series 5 Video Laryngoscope
Active Comparator: Intubation using Macintosh Laryngoscope
Tracheal intubation using Macintosh Laryngoscope
Device: Tracheal intubation using Macintosh Laryngoscope
Tracheal intubation using Macintosh Laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Time
Time Frame: At intubation
Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation
At intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Learning to Use the Scopes
Time Frame: At analysis
Is there a difference between trainee anaesthetists in learning to use the scopes
At analysis
Quality of View of the Vocal Cords
Time Frame: At analysis
At analysis
Number of Attempts to Secure Successful Intubation
Time Frame: At analysis
Is there a difference in the number of attempts required to secure successful intubation ?
At analysis
Incidence of Initial Oesophageal Intubation
Time Frame: At analysis
At analysis
Number of Intubations Taking More Than 70 Seconds
Time Frame: At Analysis
At Analysis
Incidence of Low Arterial Saturation During Intubation
Time Frame: At analysis
At analysis
Incidence of Visible Trauma to the Airway
Time Frame: At analysis
At analysis

Collaborators and Investigators

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

Sponsor

NHS Grampian

Investigators

  • Principal Investigator: william brampton, NHS Grampian

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

February 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 12, 2008

Study Record Updates

Last Update Posted (Estimate)

August 2, 2011

Last Update Submitted That Met QC Criteria

July 29, 2011

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08-so802-4

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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