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

January 19, 2012
May 30, 2012
March 2012
March 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01516164 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope
A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Tracheal Intubation
Device: Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis laryngoscopy is performed and the patient's trachea intubated.
  • Active Comparator: MacIntosh
    Intervention: Device: Laryngoscopy
  • Active Comparator: McGrath MAC direct
    Intervention: Device: Laryngoscopy
  • Active Comparator: McGrath MAC indirect
    Intervention: Device: Laryngoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
158
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01516164
2011AN04
No
Dr Claire Wallace, NHS Tayside
NHS Tayside
Not Provided
Principal Investigator: Claire D Wallace, MBChB NHS Tayside
NHS Tayside
May 2012

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