A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

Dr Claire Wallace, NHS Tayside

ClinicalTrials.gov Identifier:

NCT01516164

First received: January 19, 2012

Last updated: May 30, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 19, 2012

Last Updated Date

May 30, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intubation Difficulty Score [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

The Intubation Difficulty Scale (IDS) is a numerical score based on seven parameters. The scoring of each parameter represents a divergence from an 'ideal' condition and the total score represents a sum divergence from a zero difficulty ideal intubation. The seven parameters are number of supplementary attempts, number of supplementary operators, number and type of alternative techniques used, laryngoscopic grade, subjective lifting force, the use of external laryngeal manipulation and mobility or position of the vocal cords.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01516164 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to intubation [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Number and types of alternative techniques used [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Perception of force used [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Complications [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Ease of intubation [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
Failure to intubate [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope

Official Title ^ICMJE

A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope

Brief Summary

Videolaryngoscopes offer the potential to make tracheal intubation easier for the anaesthetist and less traumatic for the patient. This study aims to compare the intubation difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen) and the MacIntosh laryngoscopes.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Tracheal Intubation

Intervention ^ICMJE

Device: Laryngoscopy

After establishing full monitoring, inducing general anaesthesia and ensuring paralysis laryngoscopy is performed and the patient's trachea intubated.

Study Arm (s)

Active Comparator: MacIntosh
Intervention: Device: Laryngoscopy
Active Comparator: McGrath MAC direct
Intervention: Device: Laryngoscopy
Active Comparator: McGrath MAC indirect
Intervention: Device: Laryngoscopy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

158

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Elective procedure requiring oral tracheal tube intubation
Over 16 years of age
Airway assessment suggests to the anaesthetist that a standard MacIntosh laryngoscope approach to intubation would be appropriate.

Exclusion Criteria:

Emergency procedure
Less than 16 years of age
Unable to consent
Requiring Rapid Sequence Induction (a specialised anaesthetic induction technique)
Predicted difficult intubation
Not suitable for the standardised induction technique

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01516164

Other Study ID Numbers ^ICMJE

2011AN04

Has Data Monitoring Committee

Responsible Party

Dr Claire Wallace, NHS Tayside

Study Sponsor ^ICMJE

NHS Tayside

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Claire D Wallace, MBChB

NHS Tayside

Information Provided By

NHS Tayside

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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