Forces on Teeth During Videolaryngoscopy

Not Applicable

Completed

• Conditions: Intubation Complication; Tooth Injuries
• Interventions: Device: Forces exerted on teeth during intubation

• Registration Number: NCT01599312
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-08
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C-MAC®	Forces exerted on teeth during intubation	C-MAC® (Karl Storz, Tuttlingen, Germany)
McGrath®	Forces exerted on teeth during intubation	McGrath® (Aircraft Medical Ltd, Edinburgh, UK)
GlideScope® Cobalt	Forces exerted on teeth during intubation	GlideScope® Cobalt (Verathon Medical, Bothell, WA, USA)
Classic Macintosh laryngoscope	Forces exerted on teeth during intubation	Classic Macintosh laryngoscope (Karl Storz, Tuttlingen, Germany)

Primary Outcome Measures

Name	Time	Method
Measuring the frequency with which forces are applied to the upper and lower teeth.	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 Outcome Measures

Name	Time	Method
Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes.	At intubation of the patient

Trial Locations

Locations (1)

Catharina Ziekenhuis Eindhoven; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands