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

Tracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633867
• Other study ID #: 08-so802-4
• Status: Completed
• Phase: N/A
• First received: March 4, 2008
• Last updated: July 29, 2011
• Start date: February 2008
• Est. completion date: August 2008

Study information

• Verified date: March 2008
• Source: NHS Grampian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

Device:
• McGrath
Tracheal intubation, using Mcgrath video-laryngoscope
• Tracheal intubation using Macintosh Laryngoscope
Tracheal intubation using Macintosh Laryngoscope

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Hospitals, NHS Grampian	Aberdeen	UK

Sponsors (1)

Lead Sponsor	Collaborator
NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation Time	Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation	At intubation	No
Secondary	Difference in Learning to Use the Scopes	Is there a difference between trainee anaesthetists in learning to use the scopes	At analysis	No
Secondary	Quality of View of the Vocal Cords		At analysis	No
Secondary	Number of Attempts to Secure Successful Intubation	Is there a difference in the number of attempts required to secure successful intubation ?	At analysis	No
Secondary	Incidence of Initial Oesophageal Intubation		At analysis	No
Secondary	Number of Intubations Taking More Than 70 Seconds		At Analysis	Yes
Secondary	Incidence of Low Arterial Saturation During Intubation		At analysis	Yes
Secondary	Incidence of Visible Trauma to the Airway		At analysis	Yes