NCT00633867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 25, 2010

Completed
Last Updated

August 2, 2011

Status Verified

March 1, 2008

Enrollment Period

6 months

First QC Date

March 4, 2008

Results QC Date

February 25, 2010

Last Update Submit

July 29, 2011

Conditions

Tracheal Intubation

Keywords

Tracheal intubationLaryngoscopyvideolaryngoscopeMcGrathsuccesstime

Outcome Measures

Primary Outcomes (1)

  • Intubation Time

    Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation

    At intubation

Secondary Outcomes (7)

  • Difference in Learning to Use the Scopes

    At analysis

  • Quality of View of the Vocal Cords

    At analysis

  • Number of Attempts to Secure Successful Intubation

    At analysis

  • Incidence of Initial Oesophageal Intubation

    At analysis

  • Number of Intubations Taking More Than 70 Seconds

    At Analysis

  • +2 more secondary outcomes

Study Arms (2)

Intubation c McGrath videolaryngoscope

ACTIVE COMPARATOR

Tracheal Intubation using McGrath video-laryngoscope

Device: McGrath

Intubation using Macintosh Laryngoscope

ACTIVE COMPARATOR

Tracheal intubation using Macintosh Laryngoscope

Device: Tracheal intubation using Macintosh Laryngoscope

Interventions

McGrathDEVICE

Tracheal intubation, using Mcgrath video-laryngoscope

Also known as: Aircraft Medical McGrath Series 5 Video Laryngoscope
Intubation c McGrath videolaryngoscope
Tracheal intubation using Macintosh LaryngoscopeDEVICE

Tracheal intubation using Macintosh Laryngoscope

Intubation using Macintosh Laryngoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aberdeen Royal Hospitals, NHS Grampian

Aberdeen, UK, AB25 2ZN, United Kingdom

Location

Related 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 2009 Jul 15.

    PMID: 19605408RESULT

Results Point of Contact

Title
W Brampton
Organization
NHS Grampian
william.brampton@nhs.net

Study Officials

  • william brampton

    NHS Grampian

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 12, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 2, 2011

Results First Posted

March 25, 2010

Record last verified: 2008-03

Locations

GB(1)