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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
  Purpose

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.


Condition Intervention
Tracheal Intubation
 Device: Laryngoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope

Further study details as provided by NHS Tayside:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 158
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MacIntosh Device: Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis laryngoscopy is performed and the patient's trachea intubated.
Active Comparator: McGrath MAC direct Device: Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis laryngoscopy is performed and the patient's trachea intubated.
Active Comparator: McGrath MAC indirect Device: Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis laryngoscopy is performed and the patient's trachea intubated.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516164

Locations
United Kingdom
NHS Tayside
Tayside, United Kingdom
Sponsors and Collaborators
NHS Tayside
Investigators
Principal Investigator: Claire D Wallace, MBChB NHS Tayside
  More Information

No publications provided

Responsible Party: Dr Claire Wallace, Dr Claire Wallace SpR Anaesthetics, NHS Tayside
ClinicalTrials.gov Identifier: NCT01516164     History of Changes
Other Study ID Numbers: 2011AN04
Study First Received: January 19, 2012
Last Updated: May 30, 2012
Health Authority: United Kingdom: NHS Tayside R & D
United Kingdom: Research Ethics Committee

Keywords provided by NHS Tayside:
Laryngoscopy
Videolaryngoscopy
Ease of Intubation

ClinicalTrials.gov processed this record on May 16, 2013