Clinical trial NCT03265548: Video Laryngoscopy in Newborn Babies V1
Official title: Comparison Between Direct Laryngoscopy and Video Laryngoscopy for Neonatal Intubation. Confidence of Staff and Number of Attempts to Successful Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Derriford Hospital
First posted: 2017-08-29
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of attempts to successful intubation
timeFrame: 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
measure: Team confidence around tube placement at the time of tube placement
timeFrame: immediately after the intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
state: Devon
Study officials:
affiliation: Consultant at Hospital
name: Bartle Dr David, MBChB
role: PRINCIPAL_INVESTIGATOR
References: