Video Laryngoscopy in Newborn Babies V1

Study Overview
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Brief Summary
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Our research questions are Will the use of a video laryngoscope lead to decreased attempts Does this result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed.

Detailed Description
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Neonatal intubation is a technically difficult, but essential, skill to learn, involving passing a plastic tube through the vocal cords, into the trachea. Current practice involves using a laryngoscope to directly visualise the cords, however this technique does not allow the supervisor to witness the tube passing through the cords. Video laryngoscopes have a camera at the distal end of the blade, allowing an 85% viewing angle as opposed to 15% that is seen with direct view. In addition, the image is projected onto a screen, allowing all members of the team to visualise the intubation and therefore provide real time guidance as well as increased confidence in the outcome of the attempt. Video laryngoscopes are used in neonates in other specialities, for example Ear Nose and throat or respiratory physicians, and are becoming routinely used by neonatologists. The research questions are whether using a video laryngoscope will lead to decreased attempts, which in turn will potentially result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed. The aim is to recruit 40 babies and randomly allocate the participant to either direct laryngoscopy or video laryngoscopy for elective intubations. Number of attempts to successful intubation would be recorded, in addition to confidence of supervisor and the team regarding the outcome of the attempt.

Official Title
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Comparison Between Direct Laryngoscopy and Video Laryngoscopy for Neonatal Intubation. Confidence of Staff and Number of Attempts to Successful Intubation

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Device: Video Laryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any baby requiring intubation on a neonatal unit Exclusion Criteria: Infants will 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 not usually taught to registrars. Any baby with a congenital airway malformation will not be included in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>Usual Direct view laryngoscopy | |
| Experimental: Intervention<br>Video laryngoscopy | Device: Video Laryngoscope<br>* The use of video laryngoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attempts to successful intubation | How many attempts before successful intubation | Each attempt is defined by the need to stop the attempt and give non-invasive support. A maximum of 3 attempts per trainee. The eligible participant is any baby on NNU who requires intubation | 
| Team confidence around tube placement at the time of tube placement | Continuous line to score the confidence of the individuals in the team | immediately after the intubation |