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

This study has been completed.
Sponsor:
Information provided by:
NHS Grampian
ClinicalTrials.gov Identifier:
NCT00633867
First received: March 4, 2008
Last updated: July 29, 2011
Last verified: March 2008

March 4, 2008
July 29, 2011
February 2008
August 2008   (final data collection date for primary outcome measure)
Intubation Time [ Time Frame: At intubation ] [ Designated as safety issue: No ]
Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation
Primary Hypothesis - When Comparing a McGrath Videolaryngoscope With a Macintosh Is There a Clinically Significant Difference in the Time Taken to Successfully Intubate the Trachea? [ Time Frame: During Tracheal Intubation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00633867 on ClinicalTrials.gov Archive Site
  • Difference in Learning to Use the Scopes [ Time Frame: At analysis ] [ Designated as safety issue: No ]
    Is there a difference between trainee anaesthetists in learning to use the scopes
  • Quality of View of the Vocal Cords [ Time Frame: At analysis ] [ Designated as safety issue: No ]
  • Number of Attempts to Secure Successful Intubation [ Time Frame: At analysis ] [ Designated as safety issue: No ]
    Is there a difference in the number of attempts required to secure successful intubation ?
  • Incidence of Initial Oesophageal Intubation [ Time Frame: At analysis ] [ Designated as safety issue: No ]
  • Number of Intubations Taking More Than 70 Seconds [ Time Frame: At Analysis ] [ Designated as safety issue: Yes ]
  • Incidence of Low Arterial Saturation During Intubation [ Time Frame: At analysis ] [ Designated as safety issue: Yes ]
  • Incidence of Visible Trauma to the Airway [ Time Frame: At analysis ] [ Designated as safety issue: Yes ]
  • Is There a Difference Between Trainee Anaesthetists in Learning to Use the Scopes? [ Time Frame: At analysis ] [ Designated as safety issue: No ]
  • Is There a Difference in the Quality of View of the Vocal Cords Obtained ? [ Time Frame: At analysis ] [ Designated as safety issue: No ]
  • Is There a Difference in the Number of Attempts Required to Secure Successful Intubation ? [ Time Frame: At analysis ] [ Designated as safety issue: No ]
  • Is There a Difference in the Incidence of Initial Oesophageal Intubation ? [ Time Frame: At analysis ] [ Designated as safety issue: No ]
  • Is There a Difference in the Number of Intubations Taking More Than 70 Seconds? [ Time Frame: At Analysis ] [ Designated as safety issue: Yes ]
  • Is There a Difference in the Incidence of Low Arterial Saturation During Intubation? [ Time Frame: At analysis ] [ Designated as safety issue: Yes ]
  • Is There a Difference in the Incidence of Visible Trauma to the Airway? [ Time Frame: At analysis ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope
Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Tracheal Intubation
  • Device: McGrath
    Tracheal intubation, using Mcgrath video-laryngoscope
    Other Name: Aircraft Medical McGrath Series 5 Video Laryngoscope
  • Device: Tracheal intubation using Macintosh Laryngoscope
    Tracheal intubation using Macintosh Laryngoscope
  • Active Comparator: Intubation c McGrath videolaryngoscope
    Tracheal Intubation using McGrath video-laryngoscope
    Intervention: Device: McGrath
  • Active Comparator: Intubation using Macintosh Laryngoscope
    Tracheal intubation using Macintosh Laryngoscope
    Intervention: Device: Tracheal intubation using Macintosh Laryngoscope
Walker L, Brampton W, Halai M, Hoy C, Lee E, Scott I, McLernon DJ. Randomized controlled trial of intubation with the McGrath Series 5 videolaryngoscope by inexperienced anaesthetists. Br J Anaesth. 2009 Sep;103(3):440-5. Epub 2009 Jul 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00633867
08-so802-4
Yes
Doctor William Brampton, NHS Grampian
NHS Grampian
Not Provided
Principal Investigator: william brampton NHS Grampian
NHS Grampian
March 2008

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