Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope - Full Text View

Sponsored by:	NHS Grampian
Information provided by:	NHS Grampian
ClinicalTrials.gov Identifier:	NCT00633867

Purpose

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.

Condition	Intervention
Tracheal Intubation	Device: McGrath Device: Tracheal intubation using Macintosh Laryngoscope

Study Type:	Interventional
Study Design:	Treatment, Randomized, Parallel Assignment, Efficacy Study
Official Title:	Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope

Further study details as provided by NHS Grampian:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	February 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Tracheal Intubation using McGrath video-laryngoscope	Device: McGrath Tracheal intubation, using Mcgrath video-laryngoscope
2: Active Comparator Tracheal intubation using Macintosh Laryngoscope	Device: Tracheal intubation using Macintosh Laryngoscope Tracheal intubation using Macintosh Laryngoscope

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633867

Contacts

Contact: lewis walker, mbchb	+441224553238	lewis.walker@nhs.net
Contact: william brampton	+441224553238	william.brampton@nhs.net

Locations

United Kingdom, UK
Aberdeen Royal Hospitals, NHS Grampian	Recruiting
Aberdeen, UK, United Kingdom, AB25 2ZN
Contact: NHS Grampian grampian@nhs.net
Sub-Investigator: lewis walker
Principal Investigator: william brampton

Sponsors and Collaborators

NHS Grampian

Investigators

Principal Investigator:

william brampton

NHS Grampian

More Information

No publications provided by NHS Grampian

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	NHS Grampian ( Doctor William Brampton )
Study ID Numbers:	08-so802-4
Study First Received:	March 4, 2008
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00633867 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by NHS Grampian:

Tracheal intubation
Laryngoscopy
videolaryngoscope

McGrath
success
time

ClinicalTrials.gov processed this record on September 10, 2009