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Completed

NCT Number: NCT01599312

Forces on Teeth During 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.

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Key information

Conditions

Tooth Injuries Intubation Complication Stomatognathic Diseases Tooth Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forces exerted on teeth during intubation

Device

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)

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: At intubation of the patient

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 16, 2012
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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