Forces on Teeth During Videolaryngoscopy

February 8, 2015 updated by: Barbe Pieters, Catharina Ziekenhuis Eindhoven

Forces Exerted on Upper and Lower Teeth During Intubation: a Randomized, Cross-over Trial Comparing Indirect Videolaryngoscopy to Direct Videolaryngoscopy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During endotracheal intubation the anesthesiologist uses a laryngoscope blade to distract the tongue to achieve the best view of the glottis opening, thereby avoiding using the maxillary incisors as a fulcrum to lever the soft tissues upwards. Using the maxillary incisors as a fulcrum may otherwise result in dental trauma. It is obvious that contact with teeth and - even worse - the incidence of accidental dental trauma, is directly related to the difficulty of the intubation.

Indirect videolaryngoscopy has proven advantageous over direct laryngoscopy using a classic Macintosh blade, for improved viewing of the glottis, with subsequent more successful intubations, and a shorter effective airway time both in patients with normal and difficult airways. Previously, it has been demonstrated that the forces exerted by the anesthesiologist on the patient's maxillary incisors are reduced when using a VLS, compared with a classic Macintosh laryngoscope. However, only one type of VLS (V-MAC®, Karl Storz, Tuttlingen, Germany) was used or only forces applied to upper teeth were being registered.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
        • Catharina Ziekenhuis Eindhoven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Classic Macintosh laryngoscope
Classic Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany)
Device: Forces exerted on teeth during intubation
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.
Other Names:
  • 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)
Other: McGrath®
McGrath® (Aircraft Medical Ltd, Edinburgh, UK)
Device: Forces exerted on teeth during intubation
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.
Other Names:
  • 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)
Other: C-MAC®
C-MAC® (Karl Storz, Tuttlingen, Germany)
Device: Forces exerted on teeth during intubation
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.
Other Names:
  • 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)
Other: GlideScope® Cobalt
GlideScope® Cobalt (Verathon Medical, Bothell, WA, USA)
Device: Forces exerted on teeth during intubation
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.
Other Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring the frequency with which forces are applied to the upper and lower teeth.
Time Frame: At intubation of the patient
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 Outcome Measures

Outcome Measure
Time Frame
Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes.
Time Frame: At intubation of the patient
At intubation of the patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catharina Ziekenhuis Eindhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 14, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (Estimate)

May 16, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2015

Last Update Submitted That Met QC Criteria

February 8, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL39915.060.12
  • M12-1217 (Other Identifier: Catharina Ziekenhuis Eindhoven)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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