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Completed

NCT Number: NCT01609101

Oropharyngeal Space in Videolaryngoscopy

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.

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Key information

Conditions

Abrasion of Soft Palate Intubation Complication Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5602 ZA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

C-MAC ® videolaryngoscope

Device

C-MAC ® videolaryngoscope

Other names: C-MAC ® videolaryngoscope (Karl Storz, Tuttlingen, Germany)

Coopdech® videolaryngoscope

Device

Coopdech® videolaryngoscope

Other names: Coopdech® videolaryngoscope (Daiken Medical, Osaka, Japan)

McGrath® Series 5 videolaryngoscope

Device

McGrath® Series 5 videolaryngoscope

Other names: McGrath® Series 5 (Aircraft Medical, Edinburgh, UK)

Glidescope® Cobalt videolaryngoscope

Device

Glidescope® Cobalt videolaryngoscope

Other names: Glidescope® Cobalt (Verathon, Bothell, USA)

King Vision® videolaryngoscope

Device

King Vision® videolaryngoscope

Other names: King Vision® videolaryngoscope (King Systems, Noblesville, IN, USA)

Venner® videolaryngoscope

Device

Venner® videolaryngoscope

Other names: Venner® videolaryngoscope (Venner Medical, Singapore, Republic of Singapore)

McGrath® MAC

Device

McGrath® MAC (Aircraft Medical, Edinburgh, UK)

Other names: McGrath® MAC (Aircraft Medical, Edinburgh, UK)

Primary outcomes

  1. Palatopharyngeal distance

    Time frame: 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 outcomes

  1. 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

    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.

  2. Difference in palatopharyngeal distance between videolaryngoscopes

    Time frame: 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.

  3. Cormack-Lehane score

    Time frame: Participants will be followed during induction of anesthesia, an expected average of 10 min

    Registering difficulty of intubation (Cormack-Lehane score)

  4. Successful intubation

    Time frame: Participants will be followed during induction of anesthesia, an expected average of 10 min

    Registering the number of successful intubations.

  5. Use of rigid stylet

    Time frame: Participants will be followed during induction of anesthesia, an expected average of 10 min

    Use of rigid stylet during intubation

  6. Number of attempts

    Time frame: Participants will be followed during induction of anesthesia, an expected average of 10 min

    Number of intubation attempts

  7. Time until picking up endotracheal tube

    Time frame: Participants will be followed during induction of anesthesia, an expected average of 10 min

    Time until picking up endotracheal tube

  8. Epiglottic down-folding

    Time frame: Participants will be followed during induction of anesthesia, an expected average of 10 min

    Occurrence of epiglottic down-folding

  9. Complications

    Time frame: Participants will be followed during induction of anesthesia, an expected average of 10 min

    Any complication that occurs during intubation will be registered.

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 31, 2012
Registry last updated
Apr 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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