Oropharyngeal Space in Videolaryngoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barbe Pieters, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier:
NCT01609101
First received: May 24, 2012
Last updated: April 3, 2014
Last verified: April 2014

May 24, 2012
April 3, 2014
May 2012
April 2014   (final data collection date for primary outcome measure)
Palatopharyngeal distance [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01609101 on ClinicalTrials.gov Archive Site
  • Difference in palatopharyngeal distance between videolaryngoscope and classic Macintosh laryngoscope [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]
    Comparing the difference in remaining palatopharyngeal space between the different videolaryngoscopes.
  • Cormack-Lehane score [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: No ]
    Registering difficulty of intubation (Cormack-Lehane score)
  • Successful intubation [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]
    Registering the number of successful intubations.
  • Use of rigid stylet [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]
    Use of rigid stylet during intubation
  • Number of attempts [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]
    Number of intubation attempts
  • Time until picking up endotracheal tube [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: No ]
    Time until picking up endotracheal tube
  • Epiglottic down-folding [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: No ]
    Occurrence of epiglottic down-folding
  • Complications [ Time Frame: Participants will be followed during induction of anesthesia, an expected average of 10 min ] [ Designated as safety issue: Yes ]
    Any complication that occurs during intubation will be registered.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Abrasion of Soft Palate
  • Intubation Complication
  • Device: C-MAC ® videolaryngoscope
    C-MAC ® videolaryngoscope
    Other Name: C-MAC ® videolaryngoscope (Karl Storz, Tuttlingen, Germany)
  • Device: Coopdech® videolaryngoscope
    Coopdech® videolaryngoscope
    Other Name: Coopdech® videolaryngoscope (Daiken Medical, Osaka, Japan)
  • Device: McGrath® Series 5 videolaryngoscope
    McGrath® Series 5 videolaryngoscope
    Other Name: McGrath® Series 5 (Aircraft Medical, Edinburgh, UK)
  • Device: Glidescope® Cobalt videolaryngoscope
    Glidescope® Cobalt videolaryngoscope
    Other Name: Glidescope® Cobalt (Verathon, Bothell, USA)
  • Device: King Vision® videolaryngoscope
    King Vision® videolaryngoscope
    Other Name: King Vision® videolaryngoscope (King Systems, Noblesville, IN, USA)
  • Device: Venner® videolaryngoscope
    Venner® videolaryngoscope
    Other Name: Venner® videolaryngoscope (Venner Medical, Singapore, Republic of Singapore)
  • Device: McGrath® MAC
    McGrath® MAC (Aircraft Medical, Edinburgh, UK)
    Other Name: McGrath® MAC (Aircraft Medical, Edinburgh, UK)
  • Coopdech® videolaryngoscope
    Intervention: Device: Coopdech® videolaryngoscope
  • C-MAC® videolaryngoscope
    Intervention: Device: C-MAC ® videolaryngoscope
  • McGrath® Series 5 videolaryngoscope
    Intervention: Device: McGrath® Series 5 videolaryngoscope
  • Glidescope® Cobalt videolaryngoscope
    Intervention: Device: Glidescope® Cobalt videolaryngoscope
  • King Vision® videolaryngoscope
    Intervention: Device: King Vision® videolaryngoscope
  • Venner® videolaryngoscope
    Intervention: Device: Venner® videolaryngoscope
  • McGrath MAC® videolaryngoscope
    Intervention: Device: McGrath® MAC

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
489
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01609101
M12-1210, M12-1210
Yes
Barbe Pieters, Catharina Ziekenhuis Eindhoven
Catharina Ziekenhuis Eindhoven
Not Provided
Study Director: Andre A van Zundert, MD PhD FRCA Catharina Ziekenhuis Eindhoven
Catharina Ziekenhuis Eindhoven
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP