NCT01599312

Brief Summary

In this randomized crossover trial the investigators test whether three different brands of videolaryngoscopes (VLS) exhibit reduced forces on both upper and lower teeth, and compare them with a classic Macintosh laryngoscope blade.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 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

Study Start

First participant enrolled

May 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

February 10, 2015

Status Verified

February 1, 2015

Enrollment Period

4 months

First QC Date

May 14, 2012

Last Update Submit

February 8, 2015

Conditions

Tooth InjuriesIntubation Complication

Keywords

VideolaryngoscopyForcesTeeth

Outcome Measures

Primary Outcomes (1)

  • Measuring the frequency with which forces are applied to the upper and lower teeth.

    One of the three videolaryngoscopes will be placed in the patient's mouth. The measurement of forces applied to the teeth will be performed using Flexiforce® sensors.

    At intubation of the patient

Secondary Outcomes (1)

  • Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes.

    At intubation of the patient

Study Arms (4)

Classic Macintosh laryngoscope

OTHER

Classic Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany)

Device: Forces exerted on teeth during intubation

McGrath®

OTHER

McGrath® (Aircraft Medical Ltd, Edinburgh, UK)

Device: Forces exerted on teeth during intubation

C-MAC®

OTHER

C-MAC® (Karl Storz, Tuttlingen, Germany)

Device: Forces exerted on teeth during intubation

GlideScope® Cobalt

OTHER

GlideScope® Cobalt (Verathon Medical, Bothell, WA, USA)

Device: Forces exerted on teeth during intubation

Interventions

Forces exerted on teeth during intubationDEVICE

Anesthesia will be induced in the conventional matter. The classic Macintosh laryngoscope will be placed in the patient's mouth and a tube will be brought into position in front of the glottis. Hereafter, one of the three videolaryngoscopes will be placed in the patient's mouth and the endotracheal tube will be actually passed through the vocal cords. The measurement of forces applied to the teeth will be performed using Flexiforce® sensors.

Also known as: Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany), McGrath® (Aircraft Medical Ltd, Edinburgh, UK), C-MAC® (Karl Storz, Tuttlingen, Germany), GlideScope® Cobalt (Verathon Medical, Bothell, WA, USA)., Flexiforce® sensors (A201-25, Tekscan, MA, USA)
C-MAC®Classic Macintosh laryngoscopeGlideScope® CobaltMcGrath®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed patient consent
  • ASA I -III
  • Age \> 18 years
  • Elective surgery, other than head and/or throat surgery
  • Pre-operative Mallampati I -III
  • Fasted (≥6 hours)

You may not qualify if:

  • No informed patient consent
  • ASA ≥ IV
  • Age \< 18 year
  • Emergency surgery, surgery of head and/of throat
  • Locoregional anaesthesia
  • Pre-operative Mallampati IV
  • Fasted \< 6 hours
  • Pre-operative expected difficult airway
  • No teeth, bad dentition
  • Dental crowns and/or fixed partial denture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (2)

  • Lee RA, van Zundert AA, Maassen RL, Willems RJ, Beeke LP, Schaaper JN, van Dobbelsteen J, Wieringa PA. Forces applied to the maxillary incisors during video-assisted intubation. Anesth Analg. 2009 Jan;108(1):187-91. doi: 10.1213/ane.0b013e31818d1904.

    PMID: 19095848BACKGROUND

  • Lee RA, van Zundert AA, Maassen RL, Wieringa PA. Forces applied to the maxillary incisors by video laryngoscopes and the Macintosh laryngoscope. Acta Anaesthesiol Scand. 2012 Feb;56(2):224-9. doi: 10.1111/j.1399-6576.2011.02541.x. Epub 2011 Oct 14.

    PMID: 22091734BACKGROUND

MeSH Terms

Conditions

Tooth Injuries

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesWounds and Injuries

Study Officials

  • Andre A van Zundert, MD PhD FRCA

    Catharina Ziekenhuis Eindhoven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 16, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 10, 2015

Record last verified: 2015-02

Locations

NL(1)