NCT01516164

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

October 6, 2014

Status Verified

October 1, 2014

Enrollment Period

1.9 years

First QC Date

January 19, 2012

Last Update Submit

October 3, 2014

Conditions

Tracheal Intubation

Keywords

LaryngoscopyVideolaryngoscopyEase of Intubation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Time to intubation

    5 minutes

  • Number and types of alternative techniques used

    5 minutes

  • Perception of force used

    5 minutes

  • Complications

    5 minutes

  • Ease of intubation

    5 minutes

  • +1 more secondary outcomes

Study Arms (3)

MacIntosh

ACTIVE COMPARATOR
Device: Laryngoscopy

McGrath MAC direct

ACTIVE COMPARATOR
Device: Laryngoscopy

McGrath MAC indirect

ACTIVE COMPARATOR
Device: Laryngoscopy

Interventions

LaryngoscopyDEVICE

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

MacIntoshMcGrath MAC directMcGrath MAC indirect

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Tayside

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

  • Claire D Wallace, MBChB

    NHS Tayside

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Claire Wallace SpR Anaesthetics

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 24, 2012

Study Start

March 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

October 6, 2014

Record last verified: 2014-10

Locations

GB(1)