Video Laryngoscopy in Newborn Babies V1

NCT ID: NCT03265548

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-08-01

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Standard

Usual Direct view laryngoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Video laryngoscopy

Group Type EXPERIMENTAL

Video Laryngoscope

Intervention Type DEVICE

The use of video laryngoscopy

Interventions

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Video Laryngoscope

The use of video laryngoscopy

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Derriford Hospital

OTHER

Sponsor Role collaborator

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bartle Dr David, MBChB

Role: PRINCIPAL_INVESTIGATOR

Consultant at Hospital

Locations

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Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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16/SW/0013

Identifier Type: -

Identifier Source: org_study_id

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