Forces on Teeth During Videolaryngoscopy

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599312
• Other study ID #: NL39915.060.12
• Secondary ID: M12-1217
• Status: Completed
• Phase: N/A
• First received: May 14, 2012
• Last updated: February 8, 2015
• Start date: May 2012
• Est. completion date: September 2012

Study information

• Verified date: February 2015
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intubation Complication
• Tooth Injuries

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At intubation of the patient	Yes
Secondary	Measuring the magnitude of the forces being applied and registering the differences between (video)laryngoscopes.		At intubation of the patient	Yes