NCT03265548

Brief Summary

Our research questions are

  1. 1.Will the use of a video laryngoscope lead to decreased attempts
  2. 2.Does this result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

August 25, 2017

Last Update Submit

March 26, 2019

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Standard

NO INTERVENTION

Usual Direct view laryngoscopy

Intervention

EXPERIMENTAL

Video laryngoscopy

Device: Video Laryngoscope

Interventions

Video LaryngoscopeDEVICE

The use of video laryngoscopy

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any baby requiring intubation on a neonatal unit

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, EX25DW, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Bartle Dr David, MBChB

    Consultant at Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2017

First Posted

August 29, 2017

Study Start

June 1, 2016

Primary Completion

February 1, 2018

Study Completion

August 1, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)