Video Laryngoscopy in Newborn Babies V1

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: Video Laryngoscope

• Registration Number: NCT03265548
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

Brief Summary

Our research questions are

1. Will the use of a video laryngoscope lead to decreased attempts

2. 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

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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-08-25
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Primary Completion: 2018-02-01
• Study Completion: 2018-08-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention	Video Laryngoscope	Video laryngoscopy

Primary Outcome Measures

Name	Time	Method
Number of attempts to 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	How many attempts before successful intubation
Team confidence around tube placement at the time of tube placement	immediately after the intubation	Continuous line to score the confidence of the individuals in the team

Trial Locations

Locations (1)

Royal Devon and Exeter NHS Foundation Trust; 🇬🇧 Exeter, Devon, United Kingdom