Oropharyngeal Space in Videolaryngoscopy

Not Applicable

Completed

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

• Registration Number: NCT01609101
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-29
• Study First Posted: 2012-05-31
• Status Verified: 2014-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-03
• Last Update Posted: 2014-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Coopdech® videolaryngoscope	Coopdech® videolaryngoscope	-
C-MAC® videolaryngoscope	C-MAC ® videolaryngoscope	-
McGrath® Series 5 videolaryngoscope	McGrath® Series 5 videolaryngoscope	-
Glidescope® Cobalt videolaryngoscope	Glidescope® Cobalt videolaryngoscope	-
Venner® videolaryngoscope	Venner® videolaryngoscope	-
King Vision® videolaryngoscope	King Vision® videolaryngoscope	-
McGrath MAC® videolaryngoscope	McGrath® MAC	-

Primary Outcome Measures

Name	Time	Method
Palatopharyngeal distance	Participants will be followed during induction of anesthesia, an expected average of 10 min	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.

Secondary Outcome Measures

Name	Time	Method
Difference in palatopharyngeal distance between videolaryngoscope and classic Macintosh laryngoscope	Participants will be followed during induction of anesthesia, an expected average of 10 min	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.
Difference in palatopharyngeal distance between videolaryngoscopes	Participants will be followed during induction of anesthesia, an expected average of 10 min	Comparing the difference in remaining palatopharyngeal space between the different videolaryngoscopes.
Cormack-Lehane score	Participants will be followed during induction of anesthesia, an expected average of 10 min	Registering difficulty of intubation (Cormack-Lehane score)
Successful intubation	Participants will be followed during induction of anesthesia, an expected average of 10 min	Registering the number of successful intubations.
Use of rigid stylet	Participants will be followed during induction of anesthesia, an expected average of 10 min	Use of rigid stylet during intubation
Number of attempts	Participants will be followed during induction of anesthesia, an expected average of 10 min	Number of intubation attempts
Time until picking up endotracheal tube	Participants will be followed during induction of anesthesia, an expected average of 10 min	Time until picking up endotracheal tube
Epiglottic down-folding	Participants will be followed during induction of anesthesia, an expected average of 10 min	Occurrence of epiglottic down-folding
Complications	Participants will be followed during induction of anesthesia, an expected average of 10 min	Any complication that occurs during intubation will be registered.

Trial Locations

Locations (1)

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