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OpenTrials
Completed

NCT Number: NCT03265548

Video Laryngoscopy in Newborn Babies V1

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, EX25DW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video laryngoscope

Device

The use of video laryngoscopy

Primary outcomes

  1. Number of attempts to successful intubation

    Time frame: 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

  2. Team confidence around tube placement at the time of tube placement

    Time frame: immediately after the intubation

    Continuous line to score the confidence of the individuals in the team

Sponsors and collaborators

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust

Other

Collaborators

  • Derriford Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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