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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00633867
Other study ID # 08-so802-4
Secondary ID
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


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
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