Oropharyngeal Space in Videolaryngoscopy

Oropharyngeal Space in Videolaryngoscopy: a Randomised Crossover Trial Measuring Remaining Space Adjacent to the Videolaryngoscope Blade

In this randomised crossover trial we measure the space between the right side of the laryngoscope blade and the right palatopharyngeal wall in a cohort of ASA I-III patients with a normal mouth opening. We compare the remaining spaces for seven different videolaryngoscopes and compare these to a classic Macintosh laryngoscope.

Study Overview

• Status: Completed
• Conditions: Intubation Complication; Abrasion of Soft Palate
• Intervention / Treatment: Device: Coopdech® videolaryngoscope; Device: C-MAC ® videolaryngoscope; Device: McGrath® Series 5 videolaryngoscope; Device: Glidescope® Cobalt videolaryngoscope; Device: King Vision® videolaryngoscope; Device: Venner® videolaryngoscope; Device: McGrath® MAC

Detailed Description

Intubation using indirect videolaryngoscopy has many advantages over classic direct laryngoscopy using the Macintosh laryngoscope. There are many different videolaryngoscopes available, and the blade differs largely between videolaryngoscopes. Different size and angles of blades may have an impact on the space available for insertion of the endotracheal tube. The space between the blade and the palatopharyngeal wall may be reduced significantly, so that there is less room in the mouth to insert an endotracheal tube. Positioning and manoeuvring of the endotracheal tube may consequently be more difficult and may traumatize the pharynx as was described in a few case reports, especially when an endotracheal tube with a rigid stylet inserted was used.

• Study Type: Interventional
• Enrollment (Actual): 489
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Eindhoven, Noord-Brabant, Netherlands, 5602 ZA
      • Catharina Ziekenhuis Eindhoven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed patient consent
• ASA I - III
• Age > 18 years
• Elective surgery, other than head and/or neck surgery
• Pre-operative Mallampati I - III
• BMI < 35 kg/m2
• Fasted (≥6 hours)

Exclusion Criteria:

• No informed patient consent
• ASA ≥ IV
• Age < 18 year
• Emergency surgery, surgery of head and/of neck
• Locoregional anaesthesia
• Pre-operative Mallampati IV
• BMI > 35 kg/m2
• Fasted < 6 hours
• Pre-operative expected difficult airway (restrict neck movement, thyromental distance < 65mm, retrognathia)
• Bad, fragile dentition
• Dental crowns and/or fixed partial denture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Coopdech® videolaryngoscope	Device: Coopdech® videolaryngoscope; Coopdech® videolaryngoscope; Other Names: Coopdech® videolaryngoscope (Daiken Medical, Osaka, Japan)
OTHER: C-MAC® videolaryngoscope	Device: C-MAC ® videolaryngoscope; C-MAC ® videolaryngoscope; Other Names: C-MAC ® videolaryngoscope (Karl Storz, Tuttlingen, Germany)
OTHER: McGrath® Series 5 videolaryngoscope	Device: McGrath® Series 5 videolaryngoscope; McGrath® Series 5 videolaryngoscope; Other Names: McGrath® Series 5 (Aircraft Medical, Edinburgh, UK)
OTHER: Glidescope® Cobalt videolaryngoscope	Device: Glidescope® Cobalt videolaryngoscope; Glidescope® Cobalt videolaryngoscope; Other Names: Glidescope® Cobalt (Verathon, Bothell, USA)
OTHER: King Vision® videolaryngoscope	Device: King Vision® videolaryngoscope; King Vision® videolaryngoscope; Other Names: King Vision® videolaryngoscope (King Systems, Noblesville, IN, USA)
OTHER: Venner® videolaryngoscope	Device: Venner® videolaryngoscope; Venner® videolaryngoscope; Other Names: Venner® videolaryngoscope (Venner Medical, Singapore, Republic of Singapore)
OTHER: McGrath MAC® videolaryngoscope	Device: McGrath® MAC; McGrath® MAC (Aircraft Medical, Edinburgh, UK); Other Names: McGrath® MAC (Aircraft Medical, Edinburgh, UK)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Palatopharyngeal distance	Two laryngoscopes (one classic direct laryngoscope and one indirect videolaryngoscope) will subsequently be inserted into the patient's mouth at random order. With each laryngoscope the horizontal distance between the laryngoscope blade and mid-palatopharyngeal fold will be measured using an mm ruler.	Participants will be followed during induction of anesthesia, an expected average of 10 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in palatopharyngeal distance between videolaryngoscope and classic Macintosh laryngoscope	Investigating how this space differs from the space that remains on the right side of the blade of the classic Macintosh laryngoscope and the palatopharyngeal wall in the same cohort of patients.	Participants will be followed during induction of anesthesia, an expected average of 10 min
Difference in palatopharyngeal distance between videolaryngoscopes	Comparing the difference in remaining palatopharyngeal space between the different videolaryngoscopes.	Participants will be followed during induction of anesthesia, an expected average of 10 min
Cormack-Lehane score	Registering difficulty of intubation (Cormack-Lehane score)	Participants will be followed during induction of anesthesia, an expected average of 10 min
Successful intubation	Registering the number of successful intubations.	Participants will be followed during induction of anesthesia, an expected average of 10 min
Use of rigid stylet	Use of rigid stylet during intubation	Participants will be followed during induction of anesthesia, an expected average of 10 min
Number of attempts	Number of intubation attempts	Participants will be followed during induction of anesthesia, an expected average of 10 min
Time until picking up endotracheal tube	Time until picking up endotracheal tube	Participants will be followed during induction of anesthesia, an expected average of 10 min
Epiglottic down-folding	Occurrence of epiglottic down-folding	Participants will be followed during induction of anesthesia, an expected average of 10 min
Complications	Any complication that occurs during intubation will be registered.	Participants will be followed during induction of anesthesia, an expected average of 10 min

Collaborators and Investigators

• Sponsor: Catharina Ziekenhuis Eindhoven

Publications and helpful links

General Publications

• Cooper RM. Complications associated with the use of the GlideScope videolaryngoscope. Can J Anaesth. 2007 Jan;54(1):54-7. doi: 10.1007/BF03021900.
• Cross P, Cytryn J, Cheng KK. Perforation of the soft palate using the GlideScope videolaryngoscope. Can J Anaesth. 2007 Jul;54(7):588-9. doi: 10.1007/BF03022329. No abstract available.
• Hirabayashi Y. Pharyngeal injury related to GlideScope videolaryngoscope. Otolaryngol Head Neck Surg. 2007 Jul;137(1):175-6. doi: 10.1016/j.otohns.2007.02.038. No abstract available.
• Manickam BP, Adhikary SD. Re: Soft palate perforation during orotracheal intubation facilitated by the GlideScope videolaryngoscope. J Clin Anesth. 2008 Aug;20(5):401-402. doi: 10.1016/j.jclinane.2008.01.009. No abstract available.
• Vincent RD Jr, Wimberly MP, Brockwell RC, Magnuson JS. Soft palate perforation during orotracheal intubation facilitated by the GlideScope videolaryngoscope. J Clin Anesth. 2007 Dec;19(8):619-21. doi: 10.1016/j.jclinane.2007.03.010.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): April 1, 2014

Study Registration Dates

• First Submitted: May 24, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (ESTIMATE): May 31, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 4, 2014
• Last Update Submitted That Met QC Criteria: April 3, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Videolaryngoscopy; Trauma; Palatopharyngeal distance
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Cobalt
• Other Study ID Numbers: M12-1210 (OTHER: Catharina Ziekenhuis Eindhoven)