Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000527460
Ethics application status
Approved
Date submitted
16/11/2015
Date registered
22/04/2016
Date last updated
10/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can video laryngoscopy make a difference in time to successfull tracheal intubation for caesarian section: the comparison between the C-MAC Video Laryngoscope, the King Vision Video Laryngoscopes and Direct Laryngoscopy
Scientific title
Can video laryngoscopy make a difference in time to successful tracheal intubation for caesarian section: the comparison between the C-MAC Video Laryngoscope, the King Vision Video Laryngoscopes and Direct Laryngoscopy
Secondary ID [1] 288326 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intubation for caesarian section 296730 0
Condition category
Condition code
Anaesthesiology 296969 296969 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After rapid sequence induction using a combination of propofol 2mg/kg i.v., esmeron 1 mg/kg i.v. and Fentanyl 1 mcg/kg i.v. and anaesthetist used one of three intubation devices.
Direct laryngoscopy using a curved Macintosh blade is still the standard technique for tracheal intubation during C-section but the video laryngoscopes can provide an indirect view of the larynx and have been used to manage the difficult airway in the operating room.
The King Vision Video laryngoscope (KVL) (King Systems, Indianapolis, Indiana) is a new indirect two-piece design laryngoscope consisting of a reusable monitor attached to disposable blades. All blades are Macintosh #3 size and compared to a normal Macintosh #3 bladed laryngoscope appear wider and shorter. The blade is inserted into the mouth in the middle, over the centre of the tongue with a single circular movement, while its back surface is maintained against the palate and palatopharyngeal curve. Once the view of glottis is optimized, the tube is passed through the vocal cord into the trachea. We used KVL with a guiding channel. The guiding channel is positioned on the right side of the blade and acts as a conduit holding and directing the tracheal tube through the glottic opening when the vocal cords are visualized.
The C-MAC Video laryngoscope has the Macintosh # 3 or 4 blades incorporating a high-power light-emitting diode located in their distal third and extending the viewing angle from the standard 15 degrees to 80 degrees. The VL consists of two parts, a laryngoscope and a monitor, connected via a single cable. A 2-mm digital camera is sited within the shorter laryngoscope handle and a magnified image displayed on a screen. The C-MAC displaces soft tissue in a similar fashion to a classic Macintosh laryngoscope, affording room for tracheal tube insertion and consequently less need for intubating adjuncts.
Intervention code [1] 293226 0
Treatment: Devices
Comparator / control treatment
Direct laryngoscopy using a curved Macintosh blade is still the standard technique for tracheal intubation during C-section but it has important limitations, such as the impossibility to always align the oro-pharyngeal-laryngeal axes as well as the difficulty in predicting the airway-related problems by using the routine bedside screening-tests.
Control group
Active

Outcomes
Primary outcome [1] 296572 0
time to successful tracheal intubation (defined as the interval from the blade insertion to the blade removal from the mouth).
Timepoint [1] 296572 0
During induction of GA
Secondary outcome [1] 319953 0
laryngeal view according to Cormac-Lehane grade ( C/L grade 1, 2 or b, 3,4)
Timepoint [1] 319953 0
During intubation
Secondary outcome [2] 320673 0
Comparative ease of tracheal tube insertion, as subjectively assessed using a 100 mm Visual Analogue Scale with 0 mm = extremely easy and 100 mm = extremely difficult
Timepoint [2] 320673 0
Immediately following intubation
Secondary outcome [3] 320674 0
the number of attempts at intubation assessed by rewiew of surgical notes
Timepoint [3] 320674 0
Immediately following intubation
Secondary outcome [4] 320675 0
rate of successful intubation assessed by review of surgical notes. A failed intubation was defined as an attempt in which the user could not intubate the patient's trachea within two intubating attempts using the same blade, failure to intubate the trachea with the airway device within 60 sec, and patient desaturating at SaO2<92%, will lead to abandonment of the study and the airway will then be managed according to the ASA difficult airway algorithm and guidelines.
Timepoint [4] 320675 0
Immediately following intubation
Secondary outcome [5] 320676 0
Use of optimisation manoeures such as repositioning of the patient’s head, use of external laryngeal pressure, increase or decrease lifting force of the laryngoscope handle, further advancement or withdrawal of the laryngoscope blade assessed by review of surgical notes.
Timepoint [5] 320676 0
Immediately following intubation
Secondary outcome [6] 320677 0
Need for airway adjuncts such as bougie and ILMA assessed by rewiew of surgical notes.
Timepoint [6] 320677 0
Immediately following intubation

Eligibility
Key inclusion criteria
Parturients of ASA physical status 1-3, scheduled for either elective or emergency C-section
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients with the ASA physical status >3 or the predicted difficult airway requiring awake intubation will be excluded.

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)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the significance level of p < 0.01, power of 95%, clinically important difference of 15s and population standard deviation of 18 sec we are going to require 52 patients per group. In order to allow for drop outs and for ease of randomisation we are planning to recruit 60 patients per group for this parallel three group study design.
SPSS will be used for analyses the data. ANOVA will be used for normally distributed continuous data, Kruskal-Wallis for non-normally distributed continuous and ordinal categorical data and Chi-Squared test for nominal data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/03/2015
Date of last participant enrolment
Anticipated
12/09/2016
Actual
20/12/2016
Date of last data collection
Anticipated
Actual
21/12/2016
Sample size
Target
180
Accrual to date
Final
180
Recruitment outside Australia
Country [1] 7331 0
Slovenia
State/province [1] 7331 0
Ljubljana
Country [2] 7527 0
Slovenia
State/province [2] 7527 0
Ljubljana

Funding & Sponsors
Funding source category [1] 292379 0
Hospital
Name [1] 292379 0
University Clinical Centre Ljubljana, Slovenia
Country [1] 292379 0
Slovenia
Primary sponsor type
Hospital
Name
University medical center Ljubljana
Address
University medical centre Ljubljana, Zaloska 7, 1000 Ljubljana, Slovenia
Country
Slovenia
Secondary sponsor category [1] 291826 0
None
Name [1] 291826 0
University medical center Ljubljana
Address [1] 291826 0
University medical centre Ljubljana, Zaloska 7, 1000 Ljubljana, Slovenia
Country [1] 291826 0
Slovenia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293855 0
Republic of Slovenia National Medical Ethics Committe-NMEC
Ethics committee address [1] 293855 0
Zaloska 7, 1000 Ljubljana
Ethics committee country [1] 293855 0
Slovenia
Date submitted for ethics approval [1] 293855 0
12/01/2015
Approval date [1] 293855 0
10/02/2015
Ethics approval number [1] 293855 0
33/02/15

Summary
Brief summary
1. Introduction
There are few reports of using videolaryngoscopy to manage the airway for C-Section. We found no study evaluating the use of the KingVision videolaryngoscope for airway management in obstetric anaesthesia. The main goal of this study is to compare the KingVision videolaryngoscope with CMac videolaryngoscope and directoscopy with respect to time to successful intubation. The secondary outcomes are the quality of the laryngoscopic view, comparative ease of blade and tracheal tube insertion, the number of attempts at intubation, the rate of successful intubation, the use of optimization manoeuvres and the need for airway adjuncts.
2. Methods
After the Institutional Review Board Ethical Committee approval and the patients’ informed consent for general anaesthesia and endotracheal intubation, 180 parturients of ASA physical status 1-3, scheduled for either elective or emergency C-section will be included in the study. Patients with the ASA physical status >3 or the predicted difficult airway requiring awake intubation will be excluded. Patients will be assigned to three groups using a computer-generated random number table. After recruitment, a sealed envelope with the group allocation will be opened by the enrolling investigator. All intubations will be performed by experienced anaesthesiologists who have previously done more than 30 intubations with the tested devices. Patients will be preoperatively evaluated to ascertain predictive indices for difficult intubation. GA will be commenced with a classical rapid sequence induction using a combination of fentanyl 1microgram/kg, propofol 2mg/kg and succinylcholine 1.5mg/kg or rocuronium 1 mg/kg. After fasciculation wearing off, the laryngoscopy will be carried out using one of the VLs or the classical metal Macintosh blade #3 or 4.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61450 0
Dr Iva Blajic
Address 61450 0
Clinical Department of Anaesthesiology and Intensive Therapy
University Medical Centre Ljubljana
Zaloska 7
1000 Ljubljana
Country 61450 0
Slovenia
Phone 61450 0
+38640524272
Fax 61450 0
Email 61450 0
[email protected]
Contact person for public queries
Name 61451 0
Dr Iljaz Hodzovic
Address 61451 0
Section of Anaesthetics, Intensive Care & Pain Medicine
School of Medicine
Cardiff University
Heath Park
Cardiff CF14 4XN
Country 61451 0
United Kingdom
Phone 61451 0
+44 2920743109
Fax 61451 0
Email 61451 0
[email protected]
Contact person for scientific queries
Name 61452 0
A/Prof Tatjana Stopar Pintaric
Address 61452 0
Clinical Department of Anaesthesiology and Intensive Therapy
University Medical Centre Ljubljana
Zaloska 7
1000 Ljubljana
Country 61452 0
Slovenia
Phone 61452 0
0038640125228
Fax 61452 0
Email 61452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised comparison of C-MACTM and King Vision videolaryngoscopes with direct laryngoscopy in 180 obstetric patients.2019https://dx.doi.org/10.1016/j.ijoa.2018.12.008
N.B. These documents automatically identified may not have been verified by the study sponsor.