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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]

None

Universal Trial Number (UTN)

U1111-1205-8752

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

maxillofacial trauma

surgery requiring nasotracheal intubation

predicted difficult airway management

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

Other surgery

Injuries and Accidents

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]

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]

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]

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]

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]

Counted during the attempts for tracheal intubation after discontinuation of face-mask ventilation

Secondary outcome [2]

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]

Recorded after successful tracheal intubation.

Secondary outcome [3]

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]

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?

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

Final

Recruitment outside Australia

Country [1]

Czech Republic

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

General University Hospital in Prague

Address [1]

U nemocnice 2, 128 08, Prague

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee, General University Hospital

Ethics committee address [1]

Na bojisti 1, 128 08, Prague 2

Ethics committee country [1]

Czech Republic

Date submitted for ethics approval [1]

04/10/2017

Approval date [1]

19/10/2017

Ethics approval number [1]

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]

/AnzctrAttachments/374073-EC Approval 1597 17 S IV.pdf (Ethics approval)

Contacts

Principal investigator

Name

A/Prof Pavel Michalek

Address

General University Hospital (Vseobecna fakultni nemocnice)
U nemocnice 2, 128 08, Prague 2

Country

Czech Republic

Phone

+420224962243

Fax

+420224 962 118

pavel.michalek@vfn.cz

Contact person for public queries

Name

Tomas Brozek

Address

General University Hospital (Vseobecna fakultni nemocnice)
U nemocnice 2, 128 08, Prague 2

Country

Czech Republic

Phone

+420224962243

Fax

tomas.brozek@vfn.cz

Contact person for scientific queries

Name

Pavel Michalek

Address

General University Hospital (Vseobecna fakultni nemocnice)
U nemocnice 2, 128 08, Prague 2

Country

Czech Republic

Phone

+420224962243

Fax

+420224 962 118

pavel.michalek@vfn.cz

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1775	Study protocol				https://data.mendeley.com/datasets/f8d9psspkb/1

Results publications and other study-related documents

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