ANZCTR - Registration

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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Complications of newborn

Respiratory

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]

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]

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]

The duration of the intubation attempt

Secondary outcome [1]

Time taken for the intubation attempt

Timepoint [1]

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]

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]

The duration of the intubation attempt

Secondary outcome [3]

The rate of endotracheal tube adjustment following chest x-ray evaluation

Timepoint [3]

6 hours following the intubation

Secondary outcome [4]

Qualitative data will be obtained from the registrars about their experience of the intubation attempt

Timepoint [4]

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?

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]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council Program Grant

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Women's Hospital Human Research Ethics Committee

Ethics committee address [1]

The Royal Women's Hospital,
Locked Bag 300,
Grattan St and Flemmington Road,
Parkville
VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/02/2013

Approval date [1]

26/02/2013

Ethics approval number [1]

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

Dr Joyce O'Shea

Address

Department of Newborn Research
Royal Women's Hospital,
Corner of Grattan St and Flemmington Road,
Parkville,
VIC 3052

Country

Australia

Phone

+61383453775

Fax

joyce.o'shea@ggc,scot.nhs.uk

Contact person for public queries

Name

Joyce O'Shea

Address

Department of Newborn Research
Royal Women's Hospital,
Corner of Grattan St and Flemmington Road,
Parkville,
VIC 3052

Country

Australia

Phone

+61383453775

Fax

joyce.o'shea@ggc,scot.nhs.uk

Contact person for scientific queries

Name

Joyce O'Shea

Address

Department of Newborn Research
Royal Women's Hospital,
Corner of Grattan St and Flemmington Road,
Parkville,
VIC 3052

Country

Australia

Phone

+61383453775

Fax

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

Source	Title	Year of Publication	DOI
Embase	Videolaryngoscopy as an intubation training tool for neonatal trainees-a randomised controlled trial.	2014	https://dx.doi.org/10.1136/archdischild-2014-307384.1392
Embase	Videolaryngoscopy as an intubation training tool for neonatal trainees-a randomised controlled trial.	2014	https://dx.doi.org/10.1136/archdischild-2014-307384.138
Embase	Neonatal videolaryngoscopy as a teaching aid-the trainees' perspective from an RCT.	2015	https://dx.doi.org/10.1177/0036933015609821

N.B. These documents automatically identified may not have been verified by the study sponsor.

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