Video Laryngoscopy in Newborn Babies V1

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265548
• Other study ID #: 16/SW/0013
• Status: Completed
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: March 2019
• Source: Royal Devon and Exeter NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• Video Laryngoscope
The use of video laryngoscopy

Locations

Country	Name	City	State
United Kingdom	Royal Devon and Exeter NHS Foundation Trust	Exeter	Devon

Sponsors (2)

Lead Sponsor	Collaborator
Royal Devon and Exeter NHS Foundation Trust	Derriford Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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