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Trial registered on ANZCTR


Registration number
ACTRN12618000439246
Ethics application status
Approved
Date submitted
2/02/2016
Date registered
27/03/2018
Date last updated
27/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of disposable C-MAC videolaryngoscopic blades performance with randomised comparison to reusable C-MAC videolaryngoscopic blades performance on patients
Scientific title
Clinical evaluation of single-use vs reusable Macintosh and D-BLADE blades for the C-MAC videolaryngoscope performance on patients
Secondary ID [1] 288460 0
None
Universal Trial Number (UTN)
U1111-1156-5240
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
general anesthesia, videolaryngoscopy 297488 0
airway management 297489 0
Condition category
Condition code
Anaesthesiology 297677 297677 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 180 adult patients of both genders are included in this randomized controlled clinical trial, conducted at Sestre milosrdnice Clinical University Hospital in Zagreb, Croatia.. We are comparing C-MAC S, C-MAC, D-BLADE and D-BLADE S videolaryngoscopic blades using seven point intubation difficulty scores (IDS) as our primary outcome measure. Patients with predicted difficult airway are excluded. We are recording success rate, time to optimal glottic view, time to tube placement, total time to intubation, POGO score and seven point IDS. Failure of the procedure is declared if intubation is not successful after 120 seconds or if SaO2 dropped <90%. Intubations are being performed by anesthetists and residents of anesthesiology.
Intervention code [1] 293793 0
Treatment: Devices
Comparator / control treatment
Four groups are being compared: one intubated using reusable C-MAC blade, one intubated using single-use C-MAC blade, one intubated using reusable D-BLADE blade, and one intubated using single-use D-BLADE blade.
Control group
Active

Outcomes
Primary outcome [1] 297216 0
The primary outcome measure is the total time to successful intubation. The successful intubation is confirmed by end-tidal carbon dioxide partial pressure monitoring,
Timepoint [1] 297216 0
To be measured during and immediately after airway instrumentation.
Primary outcome [2] 304677 0
Another primary outcome is seven point intubation difficulty scores (IDS), which is used for objective evaluation.
Timepoint [2] 304677 0
IDS is to be determined during and immediately after airway instrumentation.
Secondary outcome [1] 320372 0
Tube placement success rate. This is going to be determined as a ratio between attempted and total intubation attempts using a particular device.
Timepoint [1] 320372 0
To be measured during and immediately after airway instrumentation.
Secondary outcome [2] 342739 0
Time to optimal glottic view. This time is going to be assessed using a video editing software when reviewing videolaryngoscopic footage. Time to optimal glottic view is the time from the blade passing the lips until best achieved visualisation of the glottis.
Timepoint [2] 342739 0
To be obtained during and immediately after airway instrumentation.
Secondary outcome [3] 342741 0
Time to tube placement. This time is going to be assessed using a video editing software when reviewing videolaryngoscopic footage. Time to tube placement the time from the blade passing the lips until completion of tracheal intubation.
Timepoint [3] 342741 0
To be measured during and immediately after airway instrumentation.
Secondary outcome [4] 342742 0
POGO (percentage of glottic opening) score. This score is going to be assessed using a video editing software when reviewing videolaryngoscopic footage. POGO score will be determined by the person who reviews the video by visual approximation.
Timepoint [4] 342742 0
To be measured during and immediately after airway instrumentation.

Eligibility
Key inclusion criteria
general anesthesia, elective surgery, non-difficult airway, ASA 1-3
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age less than 18 years, difficult airway, emergency surgery, ASA 4

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7566 0
Croatia
State/province [1] 7566 0

Funding & Sponsors
Funding source category [1] 292804 0
Hospital
Name [1] 292804 0
University Hospital Centre Sestre milosrdnice
Address [1] 292804 0
Vinogradska 29, 10000 Zagreb
Country [1] 292804 0
Croatia
Primary sponsor type
Hospital
Name
University Hospital Centre Sestre milosrdnice
Address
Vinogradska 29, 10000 Zagreb
Country
Croatia
Secondary sponsor category [1] 291542 0
Commercial sector/Industry
Name [1] 291542 0
KARL STORZ GmbH & Co. KG
Address [1] 291542 0
Mittelstrasse 8, 78532 Tuttlingen
Country [1] 291542 0
Germany

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294304 0
Eticko povjerenstvo KBC Sestre milosrdnice
Ethics committee address [1] 294304 0
Vinogradska cesta 29, 10000 Zagreb
Ethics committee country [1] 294304 0
Croatia
Date submitted for ethics approval [1] 294304 0
05/05/2014
Approval date [1] 294304 0
19/05/2014
Ethics approval number [1] 294304 0

Summary
Brief summary
Videolaryngoscopy is a simple and effective alternative to direct laryngoscopy. To our knowledge, there are no clinical studies on patients evaluating reusable metal and single-use videolaryngoscopic blades.

A total of 180 adult patients of both genders were included in this randomized controlled clinical trial. We compared C-MAC S, C-MAC, D-BLADE and D-BLADE S videolaryngoscopic blades using seven point intubation difficulty scores (IDS) as our primary outcome measure. Patients with predicted difficult airway were excluded. We recorded success rate, time to optimal glottic view, time to tube placement, total time to intubation, POGO score and seven point IDS. Failure of the procedure was declared if intubation was not successful after 120 seconds or if SaO2 dropped <90%.

Our study has shown that C-MAC blade provides better results in terms of the total time used to complete the intubation, better view of the glottis and intubation difficulty in comparison to disposable C-MAC S blade, without any differences in overall success or incidence of complications. Regarding the difference between D-BLADE and D-BLADE S, our results have shown that the use of both blades achieves similar times to successful intubation, overall success rate and complication incidence, with a statistical difference in respect of quality of laryngeal view and intubation difficulty in favour of the reusable blade.

Our results suggest that there is more difference between C-MAC and C-MAC S than D-BLADE and D-BLADE S blades, which could be the result of differences in the blade design.
Trial website
Trial related presentations / publications
Paolini JB, Donati F. Review article: Video-laryngoscopy: another tool for difficult intubation or a new paradigm in airway management? Can J Anesth/J Can Anesth 2013; 60 : 184–91

Ožegic O, Maldini B, Hostic V, Hodžovic I. Clinical Evaluation Of C-MAC S And D-BLADE S Disposable Videolaryngoscope Blades. Randomised Comparison To C-MAC Non-disposable Blades. Abstract Book of the World Airway Management Meeting (WAAM). Dublin: 2015; 85.

Hostic V, Maldini B, Novotny Z, Hodžovic I. Clinical evaluation of C-Mac D-Blade video laryngoscope: randomized comparison with C-Mac Blade and direct laryngoscopy. Abstracts from the Difficult Airway Society meeting 2014 (Br J Anaesth). Stratford-upon-Avon, UK: 2014; e894-e911. doi:10.1093/bja/aev258.

Jabre P, Leroux B, Brohon S. Comparison of Plastic Single-Use With Metallic Reusable Laryngoscope Blades for Out-of-Hospital Tracheal Intubation. Ann Emerg Med 2007; 50 : 258-63.

Greenland KB. Disposable C-MAC videolaryngoscope blade – not the same as the re-usable blade. Anaesthesia 2014; 69 : 1402-3.

Cortellazzi P, Caldiroli D, Byrne A, Sommariva A, Orena EF, Tramacera I. Defining and developing expertise in tracheal intubation using a GlideScope for anaesthetists with expertise in Macintosh direct laryngoscopy: an in-vivo longitudinal study. Anaesthesia 2014; 70 : 290-5.

Van Zundert TC, Van Zundert AA. Tracheal intubation of patients in non-standard positions requires training. Minerva Anestesiol 2013; 79 : 679-82.

Lee RA, van Zundert AA, Maassen RL et al. Forces applied to the maxillary incisors during video-assisted intubation. Anesth Analg 2009; 108 : 187-91.
Public notes

Contacts
Principal investigator
Name 63230 0
Dr Ognjen Ozegic
Address 63230 0
University Hospital Centre Sestre milosrdnice,
Vinogradska 29
10000 Zagreb
Croatia
Country 63230 0
Croatia
Phone 63230 0
+385915621469
Fax 63230 0
Email 63230 0
oozegic@yahoo.com
Contact person for public queries
Name 63231 0
Dr Iljaz Hodzovic
Address 63231 0
Anaesthetics, Intensive Care and Pain Medicine
Cardiff University and Aneurin Bevan University Health Board
Royal Gwent Hospital
Cardiff Rd, Newport NP20 2UB
Country 63231 0
United Kingdom
Phone 63231 0
+442920743109
Fax 63231 0
Email 63231 0
Hodzovic@cardiff.ac.uk
Contact person for scientific queries
Name 63232 0
Dr Iljaz Hodzovic
Address 63232 0
Anaesthetics, Intensive Care and Pain Medicine
Cardiff University and Aneurin Bevan University Health Board
Royal Gwent Hospital
Cardiff Rd, Newport NP20 2UB
Country 63232 0
United Kingdom
Phone 63232 0
+442920743109
Fax 63232 0
Email 63232 0
Hodzovic@cardiff.ac.uk

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary