Text Size

Forces on Teeth During Videolaryngoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barbe Pieters, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01599312
First received: May 14, 2012
Last updated: September 30, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Tooth Injuries
Intubation Complication
 Device: Forces exerted on teeth during intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Forces Exerted on Upper and Lower Teeth During Intubation: a Randomized, Cross-over Trial Comparing Indirect Videolaryngoscopy to Direct Videolaryngoscopy.

Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • Measuring the frequency with which forces are applied to the upper and lower teeth. [ Time Frame: At intubation of the patient ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: At intubation of the patient ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)
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)
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599312

Locations
Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Noord-Brabant, Netherlands, 5623 EJ
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
Study Director: Andre A van Zundert, MD PhD FRCA Catharina Ziekenhuis Eindhoven
  More Information

Publications:

Responsible Party: Barbe Pieters, Principal Investigator, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01599312     History of Changes
Other Study ID Numbers: NL39915.060.12, M12-1217
Study First Received: May 14, 2012
Last Updated: September 30, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Catharina Ziekenhuis Eindhoven:
Videolaryngoscopy
Forces
Teeth

Additional relevant MeSH terms:
Tooth Injuries
Tooth Diseases
Stomatognathic Diseases
Wounds and Injuries
Cobalt
 Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012