Oropharyngeal Space in Videolaryngoscopy

NCT ID: NCT01609101

Last Updated: 2014-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

489 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abrasion of Soft Palate Intubation Complication

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Coopdech® videolaryngoscope

Group Type OTHER

Coopdech® videolaryngoscope

Intervention Type DEVICE

Coopdech® videolaryngoscope

C-MAC® videolaryngoscope

Group Type OTHER

C-MAC ® videolaryngoscope

Intervention Type DEVICE

C-MAC ® videolaryngoscope

McGrath® Series 5 videolaryngoscope

Group Type OTHER

McGrath® Series 5 videolaryngoscope

Intervention Type DEVICE

McGrath® Series 5 videolaryngoscope

Glidescope® Cobalt videolaryngoscope

Group Type OTHER

Glidescope® Cobalt videolaryngoscope

Intervention Type DEVICE

Glidescope® Cobalt videolaryngoscope

King Vision® videolaryngoscope

Group Type OTHER

King Vision® videolaryngoscope

Intervention Type DEVICE

King Vision® videolaryngoscope

Venner® videolaryngoscope

Group Type OTHER

Venner® videolaryngoscope

Intervention Type DEVICE

Venner® videolaryngoscope

McGrath MAC® videolaryngoscope

Group Type OTHER

McGrath® MAC

Intervention Type DEVICE

McGrath® MAC (Aircraft Medical, Edinburgh, UK)

Interventions

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C-MAC ® videolaryngoscope

C-MAC ® videolaryngoscope

Intervention Type DEVICE

Coopdech® videolaryngoscope

Coopdech® videolaryngoscope

Intervention Type DEVICE

McGrath® Series 5 videolaryngoscope

McGrath® Series 5 videolaryngoscope

Intervention Type DEVICE

Glidescope® Cobalt videolaryngoscope

Glidescope® Cobalt videolaryngoscope

Intervention Type DEVICE

King Vision® videolaryngoscope

King Vision® videolaryngoscope

Intervention Type DEVICE

Venner® videolaryngoscope

Venner® videolaryngoscope

Intervention Type DEVICE

McGrath® MAC

McGrath® MAC (Aircraft Medical, Edinburgh, UK)

Intervention Type DEVICE

Other Intervention Names

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C-MAC ® videolaryngoscope (Karl Storz, Tuttlingen, Germany) Coopdech® videolaryngoscope (Daiken Medical, Osaka, Japan) McGrath® Series 5 (Aircraft Medical, Edinburgh, UK) Glidescope® Cobalt (Verathon, Bothell, USA) King Vision® videolaryngoscope (King Systems, Noblesville, IN, USA) Venner® videolaryngoscope (Venner Medical, Singapore, Republic of Singapore) McGrath® MAC (Aircraft Medical, Edinburgh, UK)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Barbe Pieters

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre A van Zundert, MD PhD FRCA

Role: STUDY_DIRECTOR

Catharina Ziekenhuis Eindhoven

Locations

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Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

References

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

Reference Type BACKGROUND
PMID: 17197469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17602049 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17599592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18761255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18083477 (View on PubMed)

Other Identifiers

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M12-1210

Identifier Type: OTHER

Identifier Source: secondary_id

M12-1210

Identifier Type: -

Identifier Source: org_study_id

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