Clinical trial NCT00633867: Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope
Official title: Randomised Controlled Trial of Intubation With the McGrath Series 5 Video Laryngoscope vs the Macintosh Laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Keywords: Tracheal intubation
Laryngoscopy
videolaryngoscope
McGrath
success
time
Lead sponsor: NHS Grampian
Sponsor class: OTHER_GOV
First posted: 2008-03-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Intubation Time
timeFrame: At intubation
Secondary outcomes:
measure: Difference in Learning to Use the Scopes
timeFrame: At analysis
measure: Quality of View of the Vocal Cords
timeFrame: At analysis
measure: Number of Attempts to Secure Successful Intubation
timeFrame: At analysis
measure: Incidence of Initial Oesophageal Intubation
timeFrame: At analysis
measure: Number of Intubations Taking More Than 70 Seconds
timeFrame: At Analysis
measure: Incidence of Low Arterial Saturation During Intubation
timeFrame: At analysis
measure: Incidence of Visible Trauma to the Airway
timeFrame: At analysis
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Hospitals, NHS Grampian
state: UK
Study officials:
affiliation: NHS Grampian
name: william brampton
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1093/bja/aep191. Epub 2009 Jul 15.