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Clinical Trials/NCT03265548
NCT03265548
Completed
Not Applicable

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

Royal Devon and Exeter NHS Foundation Trust1 site in 1 country39 target enrollmentJune 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome
Sponsor
Royal Devon and Exeter NHS Foundation Trust
Enrollment
39
Locations
1
Primary Endpoint
Number of attempts to successful intubation
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
August 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Royal Devon and Exeter NHS Foundation Trust
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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