Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000401257
Ethics application status
Approved
Date submitted
20/12/2017
Date registered
20/03/2018
Date last updated
3/04/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of videolaryngoscopes GlideScope and KingVision for nasotracheal intubation in maxillofacial patients with predicted difficult airway
Scientific title
A randomized comparison of videolaryngoscope GlideScope Titanium with videolaryngoscope KingVision (non-channeled blade) for nasotracheal intubation in patients with predicted difficult airway scheduled for maxillofacial procedure
Secondary ID [1] 293473 0
None
Universal Trial Number (UTN)
U1111-1205-8752
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
maxillofacial trauma 305666 0
surgery requiring nasotracheal intubation 305667 0
predicted difficult airway management 305668 0
Condition category
Condition code
Anaesthesiology 304888 304888 0 0
Anaesthetics
Surgery 304889 304889 0 0
Other surgery
Injuries and Accidents 304890 304890 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1: Nasotracheal intubation with videolaryngoscope GlideScope Titanium

1. Participants receive Study Information Pack in advance at least 1 hour prior to enrolment (the patients are acute due to maxillofacial trauma/abscess). This pack contains description of interventions, summary of risks associated with videolaryngoscopy and detailed information about the study process,
2. Nasotracheal intubation using the GlideScope Titanium videolaryngoscope
a) after standardized induction to general anaesthesia - preoxygenation, 100% oxygen for 5 min, propofol 2mg/kg, sufentanil 0,15 mcg/kg, suxamethonium 1.5 mg/kg - the GlideScope Titanium videolaryngoscope is inserted to the patient mouth in order to visualize the vocal cords. A soft tracheal tube is subsequently introduced into trachea and cuff of the tube is inflated with small amount of air to form a seal. Pressure inside the cuff is measured in order to achieve pressures 20-22 cmH20. Tracheal tube is kept in place for the duration of surgery.
b) time of device (Glidescope Titanium videolaryngoscope) - the device is inserted after induction to general anaesthesia and removed after successful insertion of tracheal tube.
c) the device is inserted by a doctor with Board Certification in Anaesthesia - anaesthetist
d) approximate duration of the videolaryngoscope in place is one minute
e) features differing from the control/comparator videolaryngoscope - different shape of the blade, different monitor for visualization of the vocal cords.,
Intervention code [1] 299842 0
Treatment: Devices
Comparator / control treatment
ARM 2: Nasotracheal intubation with videolaryngoscope KingVision non-channeled blade
1. Participants receive Study Information Pack in advance at least 1 hour prior to enrolment (the patients are acute due to maxillofacial trauma/abscess). This pack contains description of interventions, summary of risks associated with videolaryngoscopy and detailed information about the study process,
2. Nasotracheal intubation using the KingVision non-channeled blade videolaryngoscope
a) after standardized induction to general anaesthesia - preoxygenation, 100% oxygen for 5 min, propofol 2mg/kg, sufentanil 0,15 mcg/kg, suxamethonium 1.5 mg/kg - the KingVision non-channeled blade videolaryngoscope is inserted to the patient mouth in order to visualize the vocal cords. A soft tracheal tube is subsequently introduced into trachea and cuff of the tube is inflated with small amount of air to form a seal. Pressure inside the cuff is measured in order to achieve pressures 20-22 cmH20. Tracheal tube is kept in place for the duration of surgery.
b) time of device (KingVision non-channeled blade videolaryngoscope) - the device is inserted after induction to general anaesthesia and removed after successful insertion of tracheal tube.
c) the device is inserted by a doctor with Board Certification in Anaesthesia - anaesthetist
d) approximate duration of the videolaryngoscope in place is one minute
e) features different from the intervention videolaryngoscope - dissimilar shape of the blade, different monitor for visualization of the vocal cords.,
Control group
Active

Outcomes
Primary outcome [1] 304209 0
Time to tracheal intubation (sec)
timer starts at discontinuation of face-mask ventilation and stops once successful insertion of endotracheal tube is confirmed by anaesthetist (first visible etCO2 tracking on the monitor).
Timepoint [1] 304209 0
Measurement from discontinuation of face mask ventilation - after induction to general anaesthesia and confirmation of a sufficient muscle relaxation with "Train of four - TOF" zero to confirmation of successful tracheal intubation.
Secondary outcome [1] 341259 0
Total number of attempts for tracheal intubation (n)
Reported by study administrator(s) - independent person present in the operating room during tracheal intubation - to a study logbook
Timepoint [1] 341259 0
Counted during the attempts for tracheal intubation after discontinuation of face-mask ventilation
Secondary outcome [2] 341260 0
Total success rate of tracheal intubation (%)
Ability to achieve tracheal intubation within three attempts.
Reported by study administrator(s) - independent person present in the operating room during tracheal intubation - to a study logbook. Maximum three attempts allowed.
Timepoint [2] 341260 0
Recorded after successful tracheal intubation.
Secondary outcome [3] 341261 0
Visualisation of the vocal cords (1-4 points)
Modified Cormack and Lehane score (MCLS) used (Yentis and Lee, Anaesthesia 1998): 1 - full view of glottis, 2a - partial view of glottis, 2b - only posterior extremity of glottis seen or only arytenoid cartilages, 3 - only epiglottis seen, none of glottis seen, 4 - neither glottis nor epiglottis seen.
Reported by study administrator(s) - independent person present in the operating room during tracheal intubation - to a study logbook. The operator has maximum three attempts to visualize the vocal cords. During the attempts for tracheal intubation, the administrator follows the monitor and scores the MCLS.
Timepoint [3] 341261 0
Recorded best score during attempt for tracheal intubation.

Eligibility
Key inclusion criteria
1. emergency procedures of maxillofacial and dental surgery requiring nasotracheal intubation
2. expected difficult airway management - limited mouth opening (less than 2.5 cm), Mallampati score 3 or 4
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to communicate in Czech languege
2. Inability to understand and sign the informed consent
3. Expected easy tracheal intubation

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)
1. Patient will be given study information pack at least 24h prior to commencing the study
2. Randomization will be performed using the randomization freeware (www.graphad.com). Generated numbers and codes will be placed into the sealed envelopes.
3. After signing the informed consent the patient will be taken to the operating room and the sealed envelopes with the group allocation will be open.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1. randomization freeware (www.graphad.com)
2. generation of 110 codes in total (A = GlideScope, B = KingVision),
3. putting the codes into sealed envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Two parallel groups (A, B) with the equal number of patients in each group. 55 participants in the group A, 55 participants in the group B, 110 participants in total.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical software will be used - GraphPad InStat (GraphPad Software, La Jolla, CA, USA)
1. Data will be checked for normal distribution (Shapiro-Wilk test)
2. According to data distribution, data will be analyzed using Fisher´s exact test (for binomial data), unpaired T-test or Mann-Whitney U test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
26/03/2018
Actual
8/06/2018
Date of last participant enrolment
Anticipated
1/05/2020
Actual
Date of last data collection
Anticipated
5/05/2020
Actual
Sample size
Target
110
Accrual to date
29
Final
Recruitment outside Australia
Country [1] 9455 0
Czech Republic
State/province [1] 9455 0

Funding & Sponsors
Funding source category [1] 298097 0
Hospital
Name [1] 298097 0
General University Hospital in Prague
Country [1] 298097 0
Czech Republic
Primary sponsor type
Hospital
Name
General University Hospital in Prague
Address
U nemocnice 2, 128 08, Prague
Country
Czech Republic
Secondary sponsor category [1] 297174 0
None
Name [1] 297174 0
None
Address [1] 297174 0
None
Country [1] 297174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299117 0
Ethics Committee, General University Hospital
Ethics committee address [1] 299117 0
Na bojisti 1, 128 08, Prague 2
Ethics committee country [1] 299117 0
Czech Republic
Date submitted for ethics approval [1] 299117 0
04/10/2017
Approval date [1] 299117 0
19/10/2017
Ethics approval number [1] 299117 0
1597/17 S-IV

Summary
Brief summary
Background:
Videolaryngoscopy (VL) may improve intubation conditions in majority of patients, where the classical Macintosh laryngoscopy would be difficult or even may fail. Newer videolaryngoscopes posses smaller screens, they are also more portable and could be used outside the operating room. Modern videolaryngoscopes are also designed for visualization of the vocal cords in patients with limited mouth opening because of more slim shape of the blade.
VL GlideScope Titanium is non-channeled videolaryngoscope with a slim reusable titanium blade and attached monitor while the VL KingVision is a portable device that can use a special single-use slim plastic blade theoretically useful in difficult nasotracheal intubation.
Design: A randomized, interventional, single-blinded trial
Objective: To evaluate in emergency patients scheduled for maxillofacial or dental surgery under general anaesthesia and requiring nasotracheal intubation whether the application of different videolaryngoscopes in the operating room has a different time to the successful placement of endotracheal tube through a nasal route.
Primary outcome: time to successful intubation (sec)
Secondary outcomes: total number of attempts, total success rate, visualization of the larynx.
Methodology and sample size calculation:
The average time intubation using GlideScope VL was reported as 49 (SD +/- 9) sec. Statistically significant difference was set as 5 sec (10%) - sample size was calculated using freeware: http://powerandsamplesize.com, with a power of 80% and type I error of 5%, Minimum number of patients in one group was calculated as 51. Including patients who do not complete the study for various reasons we decided to enrol total number of 110 patients (55 per group).
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2302 2302 0 0
/AnzctrAttachments/374073-EC Approval 1597 17 S IV.pdf (Ethics approval)

Contacts
Principal investigator
Name 79350 0
A/Prof Pavel Michalek
Address 79350 0
General University Hospital (Vseobecna fakultni nemocnice)
U nemocnice 2, 128 08, Prague 2
Country 79350 0
Czech Republic
Phone 79350 0
+420224962243
Fax 79350 0
+420224 962 118
Email 79350 0
[email protected]
Contact person for public queries
Name 79351 0
Dr Tomas Brozek
Address 79351 0
General University Hospital (Vseobecna fakultni nemocnice)
U nemocnice 2, 128 08, Prague 2
Country 79351 0
Czech Republic
Phone 79351 0
+420224962243
Fax 79351 0
Email 79351 0
[email protected]
Contact person for scientific queries
Name 79352 0
A/Prof Pavel Michalek
Address 79352 0
General University Hospital (Vseobecna fakultni nemocnice)
U nemocnice 2, 128 08, Prague 2
Country 79352 0
Czech Republic
Phone 79352 0
+420224962243
Fax 79352 0
+420224 962 118
Email 79352 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Data will be available to anyone who wishes to access it
Available for what types of analyses?
Data will be available for the Publisher and IPD meta-analyses
How or where can data be obtained?
unrestricted access via web address
https://data.mendeley.com/datasets/f8d9psspkb/1


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1775Study protocol    https://data.mendeley.com/datasets/f8d9psspkb/1


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1775Study protocol https://data.mendeley.com/datasets/f8d9psspkb/1  https://data.mendeley.com/datasets/f8d9psspkb/1

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.