A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope

Tracheal Intubation Clinical Trial

Official title:

A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516164
• Other study ID #: 2011AN04
• Status: Completed
• Phase: N/A
• First received: January 19, 2012
• Last updated: October 3, 2014
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: October 2014
• Source: NHS Tayside
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: NHS Tayside R & DUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Videolaryngoscopes offer the potential to make tracheal intubation easier for the anaesthetist and less traumatic for the patient. This study aims to compare the intubation difficulty scores (a validated scoring system for ease of intubation) using the McGrath MAC as a videolaryngoscope, the McGrath MAC only as a direct laryngoscope (without video screen) and the MacIntosh laryngoscopes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Elective procedure requiring oral tracheal tube intubation

• Over 16 years of age

• Airway assessment suggests to the anaesthetist that a standard MacIntosh laryngoscope approach to intubation would be appropriate.

Exclusion Criteria:

• Emergency procedure

• Less than 16 years of age

• Unable to consent

• Requiring Rapid Sequence Induction (a specialised anaesthetic induction technique)

• Predicted difficult intubation

• Not suitable for the standardised induction technique

Study Design

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

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

Device:
• Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis laryngoscopy is performed and the patient's trachea intubated.

Locations

Country	Name	City	State
United Kingdom	NHS Tayside	Tayside

Sponsors (1)

Lead Sponsor	Collaborator
NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation Difficulty Score	The Intubation Difficulty Scale (IDS) is a numerical score based on seven parameters. The scoring of each parameter represents a divergence from an 'ideal' condition and the total score represents a sum divergence from a zero difficulty ideal intubation. The seven parameters are number of supplementary attempts, number of supplementary operators, number and type of alternative techniques used, laryngoscopic grade, subjective lifting force, the use of external laryngeal manipulation and mobility or position of the vocal cords.	5 minutes	No
Secondary	Time to intubation		5 minutes	No
Secondary	Number and types of alternative techniques used		5 minutes	No
Secondary	Perception of force used		5 minutes	No
Secondary	Complications		5 minutes	No
Secondary	Ease of intubation		5 minutes	No
Secondary	Failure to intubate		5 minutes	No