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Videolaryngoscopy for Intubation in Neonates: an Evaluation– a randomized controlled study (The Vine study)

A randomised controlled trial to evaluate the effect of videolaryngoscopy and verbal assistance on the rate of successful intubation in neonates

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000159752
Acronym
The VINE study
Enrollment
213
Registered
2013-02-11
Start date
2013-02-26
Completion date
2014-05-26
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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’.

Sponsors

Prof Peter Davis
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 4 Months
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026