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Forces on Teeth During Videolaryngoscopy

Primary Purpose

Tooth Injuries, Intubation Complication

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Forces exerted on teeth during intubation
Sponsored by
Catharina Ziekenhuis Eindhoven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tooth Injuries focused on measuring Videolaryngoscopy, Forces, Teeth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Catharina Ziekenhuis Eindhoven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Classic Macintosh laryngoscope

McGrath®

C-MAC®

GlideScope® Cobalt

Arm Description

Classic 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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2012
Last Updated
February 8, 2015
Sponsor
Catharina Ziekenhuis Eindhoven
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1. Study Identification

Unique Protocol Identification Number
NCT01599312
Brief Title
Forces on Teeth During Videolaryngoscopy
Official Title
Forces Exerted on Upper and Lower Teeth During Intubation: a Randomized, Cross-over Trial Comparing Indirect Videolaryngoscopy to Direct Videolaryngoscopy.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catharina Ziekenhuis Eindhoven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Injuries, Intubation Complication
Keywords
Videolaryngoscopy, Forces, Teeth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Classic Macintosh laryngoscope
Arm Type
Other
Arm Description
Classic Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany)
Arm Title
McGrath®
Arm Type
Other
Arm Description
McGrath® (Aircraft Medical Ltd, Edinburgh, UK)
Arm Title
C-MAC®
Arm Type
Other
Arm Description
C-MAC® (Karl Storz, Tuttlingen, Germany)
Arm Title
GlideScope® Cobalt
Arm Type
Other
Arm Description
GlideScope® Cobalt (Verathon Medical, Bothell, WA, USA)
Intervention Type
Device
Intervention Name(s)
Forces exerted on teeth during intubation
Other Intervention Name(s)
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)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measuring the frequency with which forces are applied to the upper and lower teeth.
Description
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.
Time Frame
At intubation of the patient
Secondary Outcome Measure Information:
Title
Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes.
Time Frame
At intubation of the patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre A van Zundert, MD PhD FRCA
Organizational Affiliation
Catharina Ziekenhuis Eindhoven
Official's Role
Study Director
Facility Information:
Facility Name
Catharina Ziekenhuis Eindhoven
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19095848
Citation
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.
Results Reference
background
PubMed Identifier
22091734
Citation
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.
Results Reference
background

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Forces on Teeth During Videolaryngoscopy

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