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Abrasion of Soft PalateNCT01609101

Oropharyngeal Space in Videolaryngoscopy

A study testing C-MAC ® videolaryngoscope, Coopdech® videolaryngoscope and McGrath® Series 5 videolaryngoscope in people with Abrasion of Soft Palate and Intubation Complication, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
C-MAC ® videolaryngoscope, Coopdech® videolaryngoscope and McGrath® Series 5 videolaryngoscope
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
489 participants
Where
1 siteNetherlands
Study dates
May 2012to Apr 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • No informed patient consent
  • ASA ≥ IV
  • Age < 18 year
  • Emergency surgery, surgery of head and/of neck
  • Locoregional anaesthesia
  • Pre-operative Mallampati IV
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Catharina Ziekenhuis Eindhoven

    Eindhoven, North Brabant, 5602 ZA

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
C-MAC ® videolaryngoscope, Coopdech® videolaryngoscope, McGrath® Series 5 videolaryngoscope, Glidescope® Cobalt videolaryngoscope, King Vision® videolaryngoscope
Keywords
Videolaryngoscopy, Palatopharyngeal distance, Trauma
Medical subject headings
Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C-MAC ® videolaryngoscopeDevice

    Also called C-MAC ® videolaryngoscope (Karl Storz, Tuttlingen, Germany)

    C-MAC ® videolaryngoscope

  • Coopdech® videolaryngoscopeDevice

    Also called Coopdech® videolaryngoscope (Daiken Medical, Osaka, Japan)

    Coopdech® videolaryngoscope

  • McGrath® Series 5 videolaryngoscopeDevice

    Also called McGrath® Series 5 (Aircraft Medical, Edinburgh, UK)

    McGrath® Series 5 videolaryngoscope

  • Glidescope® Cobalt videolaryngoscopeDevice

    Also called Glidescope® Cobalt (Verathon, Bothell, USA)

    Glidescope® Cobalt videolaryngoscope

  • King Vision® videolaryngoscopeDevice

    Also called King Vision® videolaryngoscope (King Systems, Noblesville, IN, USA)

    King Vision® videolaryngoscope

  • Venner® videolaryngoscopeDevice

    Also called Venner® videolaryngoscope (Venner Medical, Singapore, Republic of Singapore)

    Venner® videolaryngoscope

  • McGrath® MACDevice

    Also called McGrath® MAC (Aircraft Medical, Edinburgh, UK)

    McGrath® MAC (Aircraft Medical, Edinburgh, UK)

Study groups in NCT01609101
Study groupRoleWhat they receive
Coopdech® videolaryngoscopeOtherNot described
Receives: Device: Coopdech® videolaryngoscope
C-MAC® videolaryngoscopeOtherNot described
Receives: Device: C-MAC ® videolaryngoscope
McGrath® Series 5 videolaryngoscopeOtherNot described
Receives: Device: McGrath® Series 5 videolaryngoscope
Glidescope® Cobalt videolaryngoscopeOtherNot described
Receives: Device: Glidescope® Cobalt videolaryngoscope
King Vision® videolaryngoscopeOtherNot described
Receives: Device: King Vision® videolaryngoscope
Venner® videolaryngoscopeOtherNot described
Receives: Device: Venner® videolaryngoscope
McGrath MAC® videolaryngoscopeOtherNot described
Receives: Device: McGrath® MAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (9)

  1. 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.

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

  2. Difference in palatopharyngeal distance between videolaryngoscopes

    Comparing the difference in remaining palatopharyngeal space between the different videolaryngoscopes.

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

  3. Cormack-Lehane score

    Registering difficulty of intubation (Cormack-Lehane score)

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

  4. Successful intubation

    Registering the number of successful intubations.

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

  5. Use of rigid stylet

    Use of rigid stylet during intubation

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

  6. Number of attempts

    Number of intubation attempts

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

  7. Time until picking up endotracheal tube

    Time until picking up endotracheal tube

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

  8. Epiglottic down-folding

    Occurrence of epiglottic down-folding

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

  9. Complications

    Any complication that occurs during intubation will be registered.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
489 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01609101
Sponsor's protocol ID
M12-1210
Other IDs
M12-1210
Status last verified
Apr 2014
First submitted
24 May 2012
Last updated
4 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Cooper RM. Complications associated with the use of the GlideScope videolaryngoscope. Can J Anaesth. 2007 Jan;54(1):54-7. doi: 10.1007/BF03021900.

    PubMed 17197469

  • Cross P, Cytryn J, Cheng KK. Perforation of the soft palate using the GlideScope videolaryngoscope. Can J Anaesth. 2007 Jul;54(7):588-9. doi: 10.1007/BF03022329. No abstract available.

    PubMed 17602049

  • Hirabayashi Y. Pharyngeal injury related to GlideScope videolaryngoscope. Otolaryngol Head Neck Surg. 2007 Jul;137(1):175-6. doi: 10.1016/j.otohns.2007.02.038. No abstract available.

    PubMed 17599592

  • Manickam BP, Adhikary SD. Re: Soft palate perforation during orotracheal intubation facilitated by the GlideScope videolaryngoscope. J Clin Anesth. 2008 Aug;20(5):401-402. doi: 10.1016/j.jclinane.2008.01.009. No abstract available.

    PubMed 18761255

  • 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. doi: 10.1016/j.jclinane.2007.03.010.

    PubMed 18083477

Questions about this trial

What is this clinical trial studying?

A study testing C-MAC ® videolaryngoscope, Coopdech® videolaryngoscope and McGrath® Series 5 videolaryngoscope in people with Abrasion of Soft Palate and Intubation Complication, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Palatopharyngeal distance (time frame: Participants will be followed during induction of anesthesia, an expected average of 10 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01609101, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2014.

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