Videolaryngoscopy in Patients With Cervical Spine Immobilisation

Intubation; Difficult Clinical Trial

Official title:

A Randomised Crossover Trial Comparing the McGrath Series 5 Videolaryngoscope With the Macintosh Laryngoscope in Patients With Cervical Spine Immobilisation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563301
• Other study ID #: 2008AN01
• Status: Completed
• Phase: N/A
• First received: September 25, 2015
• Last updated: September 28, 2015
• Start date: August 2009
• Est. completion date: November 2012

Study information

• Verified date: September 2015
• Source: NHS Tayside
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Tracheal intubation is more difficult in patients in whom cervical spine immobilisation is maintained during tracheal intubation. The McGrath Series 5 videolaryngoscope offers a potential solution. The relatively short radius of the blade curvature combined with the internal arrangement of optimal components means that the glottis can be seen without the need for alignment of the oral, pharyngeal and tracheal axes.

The investigators propose that the McGrath Series 5 videolaryngoscope will improve the view of the larynx in patients with limited neck movements, making intubation quicker, easier and possibly safer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Elective procedure requiring tracheal intubation

• Over 16 years of age

Exclusion Criteria:

• Emergency procedure

• Less than 16 years of age

• Unable to consent

• Symptomatic gastro-oesophageal reflux disease

• Evidence of raised intracranial pressure

• Known pharyngeal pathology

Study Design

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

Related Conditions & MeSH terms

• Intubation; Difficult

Intervention

Device:
• Laryngoscopy
After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is 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	Cormack and Lehane laryngoscopy grade		5 minutes	No
Secondary	Time to intubation		5 minutes	No
Secondary	Rate of successful tracheal intubation		5 minutes	No
Secondary	Incidence of complications		5 minutes	No