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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01516164
Recruitment Status : Completed
First Posted : January 24, 2012
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Tracheal Intubation Device: Laryngoscopy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope
Study Start Date : March 2012
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Intubation Difficulty Score [ Time Frame: 5 minutes ]
    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 :
  1. Time to intubation [ Time Frame: 5 minutes ]
  2. Number and types of alternative techniques used [ Time Frame: 5 minutes ]
  3. Perception of force used [ Time Frame: 5 minutes ]
  4. Complications [ Time Frame: 5 minutes ]
  5. Ease of intubation [ Time Frame: 5 minutes ]
  6. Failure to intubate [ Time Frame: 5 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Claire Wallace, Dr Claire Wallace SpR Anaesthetics, NHS Tayside
ClinicalTrials.gov Identifier: NCT01516164     History of Changes
Other Study ID Numbers: 2011AN04
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014

Keywords provided by Dr Claire Wallace, NHS Tayside:
Laryngoscopy
Videolaryngoscopy
Ease of Intubation