Oropharyngeal Space in Videolaryngoscopy

Intubation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609101
• Other study ID #: M12-1210
• Secondary ID: M12-1210
• Status: Completed
• Phase: N/A
• First received: May 24, 2012
• Last updated: April 3, 2014
• Start date: May 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• 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 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 Design

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

Related Conditions & MeSH terms

• Abrasion of Soft Palate
• Intubation Complication

Intervention

Device:
• C-MAC ® videolaryngoscope
C-MAC ® videolaryngoscope
• Coopdech® videolaryngoscope
Coopdech® videolaryngoscope
• McGrath® Series 5 videolaryngoscope
McGrath® Series 5 videolaryngoscope
• Glidescope® Cobalt videolaryngoscope
Glidescope® Cobalt videolaryngoscope
• King Vision® videolaryngoscope
King Vision® videolaryngoscope
• Venner® videolaryngoscope
Venner® videolaryngoscope
• McGrath® MAC
McGrath® MAC (Aircraft Medical, Edinburgh, UK)

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 (5)

Cooper RM. Complications associated with the use of the GlideScope videolaryngoscope. Can J Anaesth. 2007 Jan;54(1):54-7. — View 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. — View Citation

Hirabayashi Y. Pharyngeal injury related to GlideScope videolaryngoscope. Otolaryngol Head Neck Surg. 2007 Jul;137(1):175-6. — View Citation

Manickam BP, Adhikary SD. Re: Soft palate perforation during orotracheal intubation facilitated by the GlideScope videolaryngoscope. J Clin Anesth. 2008 Aug;20(5):401-2; author reply 403. doi: 10.1016/j.jclinane.2008.01.009. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Cormack-Lehane score	Registering difficulty of intubation (Cormack-Lehane score)	Participants will be followed during induction of anesthesia, an expected average of 10 min	No
Secondary	Successful intubation	Registering the number of successful intubations.	Participants will be followed during induction of anesthesia, an expected average of 10 min	Yes
Secondary	Use of rigid stylet	Use of rigid stylet during intubation	Participants will be followed during induction of anesthesia, an expected average of 10 min	Yes
Secondary	Number of attempts	Number of intubation attempts	Participants will be followed during induction of anesthesia, an expected average of 10 min	Yes
Secondary	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	No
Secondary	Epiglottic down-folding	Occurrence of epiglottic down-folding	Participants will be followed during induction of anesthesia, an expected average of 10 min	No
Secondary	Complications	Any complication that occurs during intubation will be registered.	Participants will be followed during induction of anesthesia, an expected average of 10 min	Yes