NCT02563301

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 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

August 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

3.3 years

First QC Date

September 25, 2015

Last Update Submit

September 28, 2015

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

  • Cormack and Lehane laryngoscopy grade

    5 minutes

Secondary Outcomes (3)

  • Time to intubation

    5 minutes

  • Rate of successful tracheal intubation

    5 minutes

  • Incidence of complications

    5 minutes

Study Arms (2)

McGrath Series 5

ACTIVE COMPARATOR

Videolaryngoscope used to perform indirect (video) laryngoscopy and tracheal intubation

Device: Laryngoscopy

Macintosh

ACTIVE COMPARATOR

Laryngoscope used to perform direct laryngoscopy and tracheal intubation

Device: Laryngoscopy

Interventions

LaryngoscopyDEVICE

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

MacintoshMcGrath Series 5

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Elective procedure requiring tracheal intubation
  • Over 16 years of age

You may not qualify if:

  • Emergency procedure
  • Less than 16 years of age
  • Unable to consent
  • Symptomatic gastro-oesophageal reflux disease
  • Evidence of raised intracranial pressure
  • Known pharyngeal pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Tayside

Tayside, United Kingdom

Location

MeSH Terms

Interventions

Laryngoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Study Officials

  • Lynsey T Foulds, MBChB

    NHS Tayside

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialty Registrar Anaesthetics

Study Record Dates

First Submitted

September 25, 2015

First Posted

September 30, 2015

Study Start

August 1, 2009

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

GB(1)