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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
  Purpose

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.


Condition Intervention
Abrasion of Soft Palate
Intubation Complication
Device: C-MAC ® videolaryngoscope
Device: Coopdech® videolaryngoscope
Device: McGrath® Series 5 videolaryngoscope
Device: Glidescope® Cobalt videolaryngoscope
Device: King Vision® videolaryngoscope
Device: Venner® videolaryngoscope
Device: McGrath® MAC

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Oropharyngeal Space in Videolaryngoscopy: a Randomised Crossover Trial Measuring Remaining Space Adjacent to the Videolaryngoscope Blade

Further study details as provided by Catharina Ziekenhuis Eindhoven:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 489
Study Start Date: May 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Coopdech® videolaryngoscope Device: Coopdech® videolaryngoscope
Coopdech® videolaryngoscope
Other Name: Coopdech® videolaryngoscope (Daiken Medical, Osaka, Japan)
C-MAC® videolaryngoscope Device: C-MAC ® videolaryngoscope
C-MAC ® videolaryngoscope
Other Name: C-MAC ® videolaryngoscope (Karl Storz, Tuttlingen, Germany)
McGrath® Series 5 videolaryngoscope Device: McGrath® Series 5 videolaryngoscope
McGrath® Series 5 videolaryngoscope
Other Name: McGrath® Series 5 (Aircraft Medical, Edinburgh, UK)
Glidescope® Cobalt videolaryngoscope Device: Glidescope® Cobalt videolaryngoscope
Glidescope® Cobalt videolaryngoscope
Other Name: Glidescope® Cobalt (Verathon, Bothell, USA)
King Vision® videolaryngoscope Device: King Vision® videolaryngoscope
King Vision® videolaryngoscope
Other Name: King Vision® videolaryngoscope (King Systems, Noblesville, IN, USA)
Venner® videolaryngoscope Device: Venner® videolaryngoscope
Venner® videolaryngoscope
Other Name: Venner® videolaryngoscope (Venner Medical, Singapore, Republic of Singapore)
McGrath MAC® videolaryngoscope Device: McGrath® MAC
McGrath® MAC (Aircraft Medical, Edinburgh, UK)
Other Name: McGrath® MAC (Aircraft Medical, Edinburgh, UK)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609101

Locations
Netherlands
Catharina Ziekenhuis Eindhoven
Eindhoven, Noord-Brabant, Netherlands, 5602 ZA
Sponsors and Collaborators
Catharina Ziekenhuis Eindhoven
Investigators
Study Director: Andre A van Zundert, MD PhD FRCA Catharina Ziekenhuis Eindhoven
  More Information

Publications:
Responsible Party: Barbe Pieters, Principal Investigator, Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov Identifier: NCT01609101     History of Changes
Other Study ID Numbers: M12-1210, M12-1210
Study First Received: May 24, 2012
Last Updated: April 3, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Catharina Ziekenhuis Eindhoven:
Videolaryngoscopy
Palatopharyngeal distance
Trauma

Additional relevant MeSH terms:
Cobalt
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 20, 2014