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
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:
  • Intubation Time [ Time Frame: At intubation ] [ Designated as safety issue: No ]
    Time from anaesthetist picking up laryngoscope until 1st upward capnograph deflection after intubation


Secondary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intubation c McGrath videolaryngoscope
Tracheal Intubation using McGrath video-laryngoscope
Device: McGrath
Tracheal intubation, using Mcgrath video-laryngoscope
Other Name: Aircraft Medical McGrath Series 5 Video Laryngoscope
Active Comparator: Intubation using Macintosh Laryngoscope
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Aberdeen Royal Hospitals, NHS Grampian
Aberdeen, UK, United Kingdom, AB25 2ZN
Sponsors and Collaborators
NHS Grampian
Investigators
Principal Investigator: william brampton NHS Grampian
  More Information

Publications:
Responsible Party: Doctor William Brampton, NHS Grampian
ClinicalTrials.gov Identifier: NCT00633867     History of Changes
Other Study ID Numbers: 08-so802-4
Study First Received: March 4, 2008
Results First Received: February 25, 2010
Last Updated: July 29, 2011
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 August 20, 2014