MedNav: Improving Neonatal Life Support (NLS)

NCT ID: NCT02932683

Last Updated: 2016-10-14

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

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-04-30

Brief Summary

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This study was designed to evaluate if MedNav impacts the ability of novice resuscitators to perform Neonatal Life Support (NLS) in the simulated environment, and if this ability is maintained after a 7 week period. Testing the nul hypothesis that there is no difference in technical skill completion when performing neonatal resuscitation on a mannequin with or without MedNav, immediately after training or after a period of 7 weeks since the training episode.

Detailed Description

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Novices resuscitators (Medical Students) were invited to attend a 2 hour teaching session on neonatal resuscitation.

To ensure that the differences in outcome of Neonatal Life Support (NLS) learning are attributable to MedNav only, a simple randomisation process was carried out just prior to testing, where candidates pulled out a folded piece of paper assigning them to either

1. No MedNav on performing NLS (control arm)
2. Assistance of MedNav when performing NLS

Blinding/masking was not possible for either the candidate or faculty as the testing process involved the use of a tablet device to display the MedNav system.

On entering the room, candidates stated whether they were using MedNav or not. Each candidate was given an identical neonatal resuscitation scenario and technical skills in neonatal resuscitation were assessed using a 12-point mark sheet adapted from the Neonatal Life Support course provided by the UK Resuscitation Council. After testing, all candidates were asked to assess their confidence in performing NLS using a seven point Likert scale.

Candidates were subsequently invited back for a follow-up session at 7 weeks. Testing of the same NLS scenario was undertaken with participants staying in their initial allocation groups. Again technical skills were assessed based on the UK resuscitation council mark sheet and candidates were asked to rate their confidence on NLS after.

For further analysis, a small sample of 9 students from the "non-MedNav" group were asked to perform NLS with the use of MedNav immediately after their secondary testing at 7 weeks. The investigators aim here was to assess if this crossover group had a significant improvement in their task completion owing largely to the use of MedNav.

Conditions

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Infant Showing No Response to Resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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MedNav assisted resuscitators

MedNav will be used to perform neonatal resuscitation on a mannequin and assessed after teaching and 7 weeks after intervention, following this a small group will be used as a cross over study.

Group Type EXPERIMENTAL

MedNav

Intervention Type DEVICE

MedNav is a tablet based platform that uses auditory and visual cues to prompt people to perform the correct steps in neonatal resuscitation.

No MedNav resuscitators

Neonatal resuscitation will be performed on a mannequin (without the use of MedNav) and assessed after teaching and 7 weeks after intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MedNav

MedNav is a tablet based platform that uses auditory and visual cues to prompt people to perform the correct steps in neonatal resuscitation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Imperial Medical students Novice to Neonatal resuscitation Medical students with1 year of clinical experience.

Exclusion Criteria

Previous Neonatal training,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chelsea and Westminster NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shane P Duffy, MBChB

Role: STUDY_DIRECTOR

Chelsea and Westminster Hospital

Locations

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Chelsea and Westminster NHS Foundation trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ChelseaNHS

Identifier Type: -

Identifier Source: org_study_id

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