Clinical trial NCT01599312: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Injuries
Intubation Complication
Keywords: Videolaryngoscopy
Forces
Teeth
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Measuring the frequency with which forces are applied to the upper and lower teeth.
timeFrame: At intubation of the patient
Secondary outcomes:
measure: Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes.
timeFrame: At intubation of the patient
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Andre A van Zundert, MD PhD FRCA
role: STUDY_DIRECTOR
References:
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.
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.