NCT01609101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
489

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 4, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

May 24, 2012

Last Update Submit

April 3, 2014

Conditions

Abrasion of Soft PalateIntubation Complication

Keywords

VideolaryngoscopyPalatopharyngeal distanceTrauma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

  • Difference in palatopharyngeal distance between videolaryngoscope and classic Macintosh laryngoscope

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

  • Difference in palatopharyngeal distance between videolaryngoscopes

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

  • Cormack-Lehane score

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

  • Successful intubation

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

  • Use of rigid stylet

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

  • +4 more secondary outcomes

Study Arms (7)

Coopdech® videolaryngoscope

OTHER
Device: Coopdech® videolaryngoscope

C-MAC® videolaryngoscope

OTHER
Device: C-MAC ® videolaryngoscope

McGrath® Series 5 videolaryngoscope

OTHER
Device: McGrath® Series 5 videolaryngoscope

Glidescope® Cobalt videolaryngoscope

OTHER
Device: Glidescope® Cobalt videolaryngoscope

King Vision® videolaryngoscope

OTHER
Device: King Vision® videolaryngoscope

Venner® videolaryngoscope

OTHER
Device: Venner® videolaryngoscope

McGrath MAC® videolaryngoscope

OTHER
Device: McGrath® MAC

Interventions

C-MAC ® videolaryngoscopeDEVICE

C-MAC ® videolaryngoscope

Also known as: C-MAC ® videolaryngoscope (Karl Storz, Tuttlingen, Germany)
C-MAC® videolaryngoscope
Coopdech® videolaryngoscopeDEVICE

Coopdech® videolaryngoscope

Also known as: Coopdech® videolaryngoscope (Daiken Medical, Osaka, Japan)
Coopdech® videolaryngoscope
McGrath® Series 5 videolaryngoscopeDEVICE

McGrath® Series 5 videolaryngoscope

Also known as: McGrath® Series 5 (Aircraft Medical, Edinburgh, UK)
McGrath® Series 5 videolaryngoscope
Glidescope® Cobalt videolaryngoscopeDEVICE

Glidescope® Cobalt videolaryngoscope

Also known as: Glidescope® Cobalt (Verathon, Bothell, USA)
Glidescope® Cobalt videolaryngoscope
King Vision® videolaryngoscopeDEVICE

King Vision® videolaryngoscope

Also known as: King Vision® videolaryngoscope (King Systems, Noblesville, IN, USA)
King Vision® videolaryngoscope
Venner® videolaryngoscopeDEVICE

Venner® videolaryngoscope

Also known as: Venner® videolaryngoscope (Venner Medical, Singapore, Republic of Singapore)
Venner® videolaryngoscope
McGrath® MACDEVICE

McGrath® MAC (Aircraft Medical, Edinburgh, UK)

Also known as: McGrath® MAC (Aircraft Medical, Edinburgh, UK)
McGrath MAC® videolaryngoscope

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5602 ZA, Netherlands

Location

Related Publications (5)

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

    PMID: 17197469BACKGROUND

  • 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.

    PMID: 17602049BACKGROUND

  • 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.

    PMID: 17599592BACKGROUND

  • 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.

    PMID: 18761255BACKGROUND

  • 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.

    PMID: 18083477BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Andre A van Zundert, MD PhD FRCA

    Catharina Ziekenhuis Eindhoven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 31, 2012

Study Start

May 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 4, 2014

Record last verified: 2014-04

Locations

NL(1)