Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000159752
Ethics application status
Approved
Date submitted
8/02/2013
Date registered
11/02/2013
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Videolaryngoscopy for Intubation in Neonates: an Evaluation– a randomized controlled study (The Vine study)
Scientific title
A randomised controlled trial to evaluate the effect of videolaryngoscopy and verbal assistance on the rate of successful intubation in neonates
Secondary ID [1] 281872 0
none
Universal Trial Number (UTN)
Trial acronym
The VINE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intubation of the neonatal trachea 288254 0
Condition category
Condition code
Reproductive Health and Childbirth 288649 288649 0 0
Complications of newborn
Respiratory 288650 288650 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants in the intervention group will be intubated orally by a neonatal trainee using a videolaryngoscope. The attached monitor will be displaying real time images that are visible to a supervisor who is in attendance, supervising and assisting with the intubation attempt. The intervention is the verbal assistance offered during the intubation attempt by the supervisor on seeing ‘what the intubator can see’.
Intervention code [1] 286471 0
Other interventions
Comparator / control treatment
The infants in the control group will also be intubated orally by a neonatal trainee and the laryngoscope used will also be the videolaryngoscope. However, the attached monitor screen will remain covered during the intubation attempt and the images therefore not be visible to the attending supervisor. The supervisor can still offer verbal guidance and assistance, as is standard current practice.
Control group
Active

Outcomes
Primary outcome [1] 288805 0
The rate of successful intubation on first attempt. An attempted intubation will be defined as the insertion of the laryngoscope into the infant’s mouth.
Timepoint [1] 288805 0
The duration of the intubation attempt
Secondary outcome [1] 301031 0
Time taken for the intubation attempt
Timepoint [1] 301031 0
The time taken is defined by the time difference between when the laryngoscope is inserted and subsequently removed from the patient’s mouth.
Secondary outcome [2] 301032 0
The lowest oxygen saturation and heart rate during the procedure. The oxygen saturation will be read from the attached pulsoximeter and the heart rate read either from the pulseoximeter or the infants electrocardiograph recording if attached.
Timepoint [2] 301032 0
The duration of the intubation attempt
Secondary outcome [3] 301033 0
The rate of endotracheal tube adjustment following chest x-ray evaluation
Timepoint [3] 301033 0
6 hours following the intubation
Secondary outcome [4] 301034 0
Qualitative data will be obtained from the registrars about their experience of the intubation attempt
Timepoint [4] 301034 0
Recorded as soon as possible after the intubation attempt

Eligibility
Key inclusion criteria
Infants in the delivery room, operating theatre or in the Newborn Intensive and Special Care (NISC) unit of The Royal Women’s Hospital, Melbourne who require oral endotracheal intubation will be eligible for entry to this study.
Minimum age
0 Hours
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants will be not be recruited if they are in extremis requiring immediate intubation by a senior experienced operator who will use his/her own preferred method.
Infants who will be intubated nasally will not be included as this technique is generally not taught to registrars.

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)
Sealed opaque, sequentially numbered envelopes will contain the allocation. Once the decision is made to intubate, the infant will be enrolled. Just before the intubation attempt commences, an envelope will be opened revealling the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be stratified according to whether or not the clinical team prescribe premedication. Variable block randomisation will be used within each stratification group.
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
In a trial performed at the Royal Women’s Hospital recently - A Randomized Trial of Stylets for Intubating Newborn Infants, 228 intubations by registrars were examined of which 115 were successful on first attempt (50%). Assuming a success rate of 50% in the control group, a sample size of 103 and 103 for the two groups would have a power of 80% to detect a 20% absolute difference in success rates between the groups (50% versus 70%).
The data will be presented as mean (standard deviation) for normally distributed variables and median (interquartile range) when the distribution is skewed. The clinical characteristics and outcome variables will be analysed by using the Student t test for parametric and Mann-Whitney U test for nonparametric comparisons of continuous variables and Chi squared for categorical variables. P values will be 2-sided and P values of less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/02/2013
Actual
26/02/2013
Date of last participant enrolment
Anticipated
Actual
26/05/2014
Date of last data collection
Anticipated
Actual
26/05/2014
Sample size
Target
210
Accrual to date
Final
213
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 551 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 6291 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 286699 0
Government body
Name [1] 286699 0
National Health and Medical Research Council Program Grant
Country [1] 286699 0
Australia
Primary sponsor type
Individual
Name
Prof Peter Davis
Address
Department of Newborn Research,
The Royal Women's Hospital,
Locked Bag 300,
Corner of Grattan Street and Flemmington Road,
Parkville,
VIC 3052
Country
Australia
Secondary sponsor category [1] 285470 0
None
Name [1] 285470 0
Address [1] 285470 0
Country [1] 285470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288765 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 288765 0
The Royal Women's Hospital,
Locked Bag 300,
Grattan St and Flemmington Road,
Parkville
VIC 3052
Ethics committee country [1] 288765 0
Australia
Date submitted for ethics approval [1] 288765 0
20/02/2013
Approval date [1] 288765 0
26/02/2013
Ethics approval number [1] 288765 0
13/05

Summary
Brief summary
This study is looking at methods used to intubate (insert a breathing tube that connects to a ventilator) sick infants. The standard method, which has been used internationally for many years, involves the doctor first inserting a laryngoscope into the infant’s mouth. This is an L-shaped device with a light at the tip. When it is manipulated correctly, it moves the infant’s tongue and jaw allowing a view of the infant’s airway. The doctor can then insert the breathing tube through the voice-box into the airway. This is a difficult procedure for doctors to learn and more than one attempt is often required to insert the breathing tube correctly. A more senior supervising doctor is usually present to assist during the procedure but is limited by the fact that he/she cannot see in the infant’s mouth.
The devise being examined in this study is a videolaryngoscope. This is structurally the same as a traditional laryngoscope but displays real time images on to a nearby monitor. This essentially means that the assisting doctor can now see what the intubating doctor sees and can therefore potentially offer improved guidance and assistance.
This is a randomised controlled trial and any infant at the Royal Women’s Hospital, Melbourne, who requires intubation, is eligible for inclusion. If the infant is very sick and needs urgent intubation, they are excluded. All intubations in the study will be performed by neonatal registrars, who are junior doctors in training. The enrolled infants will be allocated randomly into the intervention group or the control group. In the intervention group, the registrar will attempt to intubate the infant using the videolaryngoscope and standard breathing tubes. A supervising doctor will be present and view the videolaryngoscope screen. They will offer instruction to the registrar based on the images they see. In the control group, the registrar will attempt to intubate using the videolaryngoscope and standard breathing tubes. However this time, the monitor will remain covered during the intubation attempt. The registrar will still be offered verbal guidance, as would be standard current practice. In both groups it will be recorded if the first attempt resulted in correct placement of the breathing tube. The main result of the study will be a comparison of the rate of correct tube placement between the two groups.
Trial website
Trial related presentations / publications
Publications
1 A Randomized Trial of Videolaryngoscopy to Teach Neonatal Intubation. JE O’Shea JE, Thio M, Kamlin COF, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG. Pediatrics 2015;136(5):912-9.
2.Analysis of unsuccessful intubations in neonates using videolaryngoscopy recordings. O'Shea JE, Loganathan P, Thio M, Kamlin COF, Davis PG. Arch Dis Child Fetal Neonatal Ed. 2017 Nov 10.

Presentations
June 2015: Neonatal Society UK
• Videolaryngoscopy as an Intubation Training Tool for Neonatal Trainees – a Randomised Controlled Trial. O’Shea JE, Thio M, Kamlin COF, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG

April 2015: Perinatal Society of Australia and New Zealand
• Videolaryngoscopy as an Intubation Training Tool for Neonatal Trainees – a Randomised Controlled Trial. O’Shea JE, Thio M, Kamlin COF, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG

November 2014: Cool Topics Melbourne
• Neonatal Intubation in an Era of Reduced Opportunity. O’Shea JE

October 2014: European Society of Paediatric Research
• Videolaryngoscopy as an Intubation Training Tool for Neonatal Trainees – a Randomised Controlled Trial. O’Shea JE, Thio M, Kamlin COF, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG
Public notes

Contacts
Principal investigator
Name 37498 0
Dr Joyce O'Shea
Address 37498 0
Department of Newborn Research
Royal Women's Hospital,
Corner of Grattan St and Flemmington Road,
Parkville,
VIC 3052
Country 37498 0
Australia
Phone 37498 0
+61383453775
Fax 37498 0
Email 37498 0
joyce.o'shea@ggc,scot.nhs.uk
Contact person for public queries
Name 37499 0
Dr Joyce O'Shea
Address 37499 0
Department of Newborn Research
Royal Women's Hospital,
Corner of Grattan St and Flemmington Road,
Parkville,
VIC 3052
Country 37499 0
Australia
Phone 37499 0
+61383453775
Fax 37499 0
Email 37499 0
joyce.o'shea@ggc,scot.nhs.uk
Contact person for scientific queries
Name 37500 0
Dr Joyce O'Shea
Address 37500 0
Department of Newborn Research
Royal Women's Hospital,
Corner of Grattan St and Flemmington Road,
Parkville,
VIC 3052
Country 37500 0
Australia
Phone 37500 0
+61383453775
Fax 37500 0
Email 37500 0
joyce.oshea@thewomens.org.au

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
EmbaseNeonatal videolaryngoscopy as a teaching aid-the trainees' perspective from an RCT.2015https://dx.doi.org/10.1177/0036933015609821
EmbaseVideolaryngoscopy as an intubation training tool for neonatal trainees-a randomised controlled trial.2014https://dx.doi.org/10.1136/archdischild-2014-307384.1392
EmbaseVideolaryngoscopy as an intubation training tool for neonatal trainees-a randomised controlled trial.2014https://dx.doi.org/10.1136/archdischild-2014-307384.138
N.B. These documents automatically identified may not have been verified by the study sponsor.