Video Laryngoscopy in Newborn Babies V1

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Device: Video Laryngoscope

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Exeter, Devon, United Kingdom, EX25DW
      • Royal Devon and Exeter NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard; Usual Direct view laryngoscopy
Experimental: Intervention; Video laryngoscopy	Device: Video Laryngoscope; The use of video laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Royal Devon and Exeter NHS Foundation Trust
• Collaborators: Derriford Hospital
• Investigators: Principal Investigator: Bartle Dr David, MBChB, Consultant at Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 16/SW/0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No