Clinical trial NCT01609101: Oropharyngeal Space in Videolaryngoscopy
Official title: Oropharyngeal Space in Videolaryngoscopy: a Randomised Crossover Trial Measuring Remaining Space Adjacent to the Videolaryngoscope Blade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abrasion of Soft Palate
Intubation Complication
Keywords: Videolaryngoscopy
Palatopharyngeal distance
Trauma
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Palatopharyngeal distance
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
Secondary outcomes:
measure: Difference in palatopharyngeal distance between videolaryngoscope and classic Macintosh laryngoscope
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
measure: Difference in palatopharyngeal distance between videolaryngoscopes
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
measure: Cormack-Lehane score
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
measure: Successful intubation
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
measure: Use of rigid stylet
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
measure: Number of attempts
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
measure: Time until picking up endotracheal tube
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
measure: Epiglottic down-folding
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
measure: Complications
timeFrame: Participants will be followed during induction of anesthesia, an expected average of 10 min
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: Cooper RM. Complications associated with the use of the GlideScope videolaryngoscope. Can J Anaesth. 2007 Jan;54(1):54-7. doi: 10.1007/BF03021900.
citation: 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.
citation: 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.
citation: 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.
citation: 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.