Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001493437
Ethics application status
Approved
Date submitted
15/10/2016
Date registered
27/10/2016
Date last updated
1/08/2019
Date data sharing statement initially provided
1/08/2019
Date results information initially provided
1/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of videolaryngoscopes GlideScope and KingVision for tracheal intubation in obese patients
Scientific title
A comparison of videolaryngoscope GlideScope Titan with videolaryngoscope KingVision (channeled blade) for tracheal intubation in obese patients undergoing elective surgical procedures
Secondary ID [1] 289633 0
Nil known
Universal Trial Number (UTN)
U1111-1185-1683
Trial acronym
Glidescope/KingVision
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 299422 0
surgery requiring tracheal intubation 299423 0
Condition category
Condition code
Anaesthesiology 299401 299401 0 0
Anaesthetics
Surgery 299402 299402 0 0
Other surgery
Diet and Nutrition 299403 299403 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1 - Tracheal intubation with the videolaryngoscope KingVision (channeled blade)

1. Participants receive Study Information Pack in advance at least 1 day prior to enrollment. This pack contains description of interventions, summary of risks associated with videolaryngoscopy,
1. Tracheal intubation using the KingVision videolaryngoscope with a channeled blade
a) after standardized induction to general anaesthesia - preoxygenation, 100% oxygen, CPAP 5 cmH20 for 5 min, propofol 2mg/kg, sufentanil 0,15 mcg/kg, rocuronium 0,6 mg/kg - the KingVision videolaryngoscope with a channeled blade is inserted to the patient mouth in order to visualize the vocal cords. 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 meaured in order to achieve pressures 20-22 cmH20. Tracheal tube is kept in place for the duration of surgery.
b) time of device (KingVision 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, special channel incorporated within the blade for guiding the tracheal tube.
Intervention code [1] 295247 0
Treatment: Devices
Comparator / control treatment
ARM 2 - Tracheal intubation with the videolaryngoscope GlideScope Titan

1. Participants receive Study Information Pack in advance at least 1 day prior to enrollment. This pack contains description of interventions, summary of risks associated with videolaryngoscopy,
1. Tracheal intubation using the GlideScope videolaryngoscope
a) after standardized induction to general anaesthesia - preoxygenation, 100% oxygen, CPAP 5 cmH20 for 5 min, propofol 2mg/kg, sufentanil 0,15 mcg/kg, rocuronium 0,6 mg/kg - the GlideScope Titan videolaryngoscope with a channeled blade is inserted to the patient mouth in order to visualize the vocal cords. 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 meaured in order to achieve pressures 20-22 cmH20. Tracheal tube is kept in place for the duration of surgery.
b) time of device (GlideScope 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 of the control/comparator videolaryngoscope - specially designed videolaryngoscopic blade for difficult intubation scenarios
Control group
Active

Outcomes
Primary outcome [1] 299508 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] 299508 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] 327364 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] 327364 0
Counted during the attempts for tracheal intubation after discontinuation of face-mask ventilation
Secondary outcome [2] 327365 0
Total success rate of tracheal intubation (%)
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] 327365 0
Recorded after successful tracheal intubation.
Secondary outcome [3] 327366 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. Maximum three attempts allowed.
Timepoint [3] 327366 0
Recorded best score during attempt for tracheal intubation.

Eligibility
Key inclusion criteria
1. elective procedure requiring airway management with tracheal intubation
2. elective surgery - gynaecology, general surgery, urology, maxillofacial surgery, ENT, orthopaedics
2. obesity with Body Mass Index (BMI) more than 35 kg/m2
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mouth opening less than 2 cm
History of difficult intubation
Emergency surgery
Increased risk for gastric content regurgitation and/or aspiration
Body Mass Index (BMI) less than 35 kg/m2
Inability to communicate in Czech language

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
Completed
Date of first participant enrolment
Anticipated
2/01/2017
Actual
4/01/2017
Date of last participant enrolment
Anticipated
3/05/2018
Actual
21/05/2018
Date of last data collection
Anticipated
4/05/2018
Actual
22/05/2018
Sample size
Target
110
Accrual to date
Final
110
Recruitment outside Australia
Country [1] 8321 0
Czech Republic
State/province [1] 8321 0

Funding & Sponsors
Funding source category [1] 294721 0
Hospital
Name [1] 294721 0
General University Hospital in Prague
Country [1] 294721 0
Czech Republic
Funding source category [2] 294722 0
University
Name [2] 294722 0
1st Medical Faculty, Charles University in Prague
Country [2] 294722 0
Czech Republic
Primary sponsor type
Hospital
Name
General University Hospital (Vseobecna fakultni nemocnice)
Address
U nemocnice 2, 128 08, Prague
Country
Czech Republic
Secondary sponsor category [1] 293565 0
None
Name [1] 293565 0
Not applicable
Address [1] 293565 0
Not applicable
Country [1] 293565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296140 0
Ethics Committee, General University Hospital
Ethics committee address [1] 296140 0
Na bojisti 1, 128 08, Prague 2
Ethics committee country [1] 296140 0
Czech Republic
Date submitted for ethics approval [1] 296140 0
09/05/2016
Approval date [1] 296140 0
19/05/2016
Ethics approval number [1] 296140 0
826/16 S-IV

Summary
Brief summary
Background:
Videolaryngoscopy (VL) may improve intubation conditions in patients, where the classical laryngoscopy is difficult or even fails. Current videolaryngoscopes have smaller screens, they are more portable and could be used outside the operating room. Current videolaryngoscopes follow two concepts - a specially curved blade with optics allowing visualization of the anatomically shifted larynx (tracheal tube is usually introduced with a stylet). The second type uses an insertion channel, which allows direct placement of endotracheal tube into the trachea.
VL GlideScope Titan uses the first concept while VL KingVision is a portable tool that uses both types of blades (both concepts described above). A blade with integrated intubating channel will be used in this study.
Design: A randomized, interventional, single-blinded trial
Objective: To evaluate in obese patients (BMI more than 35 kg / m2) whether the application of different videolaryngoscopes in the operating room has a different time to the successful placement of endotracheal tube.
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 enroll total number of 110 patients (55 per group).
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1177 1177 0 0
/AnzctrAttachments/371050-Ethical Approval Brozek.pdf

Contacts
Principal investigator
Name 67258 0
A/Prof Pavel Michalek
Address 67258 0
U nemocnice 2, 128 08, Prague 2
Country 67258 0
Czech Republic
Phone 67258 0
+420224962243
Fax 67258 0
Email 67258 0
[email protected]
Contact person for public queries
Name 67259 0
Dr Tomas Brozek
Address 67259 0
U nemocnice 2, 128 08, Prague 2
Country 67259 0
Czech Republic
Phone 67259 0
+420224962243
Fax 67259 0
Email 67259 0
[email protected]
Contact person for scientific queries
Name 67260 0
A/Prof Pavel Michalek
Address 67260 0
U nemocnice 2, 128 08, Prague 2
Country 67260 0
Czech Republic
Phone 67260 0
+420224962243
Fax 67260 0
Email 67260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo 5th European Airway Management Congress, Catania, ... [More Details] 371050-(Uploaded-30-07-2019-22-27-11)-Other results publication.pdf

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
540Conference abstractNo 5th European Airway Management Congress, Catania, ... [More Details] 371050-(Uploaded-30-07-2019-22-27-11)-Other results publication.pdf
3042Plain language summaryNo Intubation time was slightly shorter in Glidescope... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized comparison of non-channeled glidescopetm titanium versus channeled kingvisiontm videolaryngoscope for orotracheal intubation in obese patients with bmi > 35 kg.m-2.2020https://dx.doi.org/10.3390/diagnostics10121024
N.B. These documents automatically identified may not have been verified by the study sponsor.