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Video Laryngoscopy in Newborn Babies V1

Primary Purpose

Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Video Laryngoscope
Sponsored by
Royal Devon and Exeter NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Respiratory Distress Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Devon and Exeter NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard

Intervention

Arm Description

Usual Direct view laryngoscopy

Video laryngoscopy

Outcomes

Primary Outcome Measures

Number of attempts to successful intubation
How many attempts before successful intubation
Team confidence around tube placement at the time of tube placement
Continuous line to score the confidence of the individuals in the team

Secondary Outcome Measures

Full Information

First Posted
August 25, 2017
Last Updated
March 26, 2019
Sponsor
Royal Devon and Exeter NHS Foundation Trust
Collaborators
Derriford Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03265548
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Devon and Exeter NHS Foundation Trust
Collaborators
Derriford Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Our research questions are Will the use of a video laryngoscope lead to decreased attempts 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
No Intervention
Arm Description
Usual Direct view laryngoscopy
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Video laryngoscopy
Intervention Type
Device
Intervention Name(s)
Video Laryngoscope
Intervention Description
The use of video laryngoscopy
Primary Outcome Measure Information:
Title
Number of attempts to successful intubation
Description
How many attempts before 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
Title
Team confidence around tube placement at the time of tube placement
Description
Continuous line to score the confidence of the individuals in the team
Time Frame
immediately after the intubation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartle Dr David, MBChB
Organizational Affiliation
Consultant at Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Devon and Exeter NHS Foundation Trust
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX25DW
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Video Laryngoscopy in Newborn Babies V1

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