MedNav: Improving Neonatal Life Support (NLS)

Mednav: A Randomised Control Trial of Novice Users of Mednav a Neonatal Resuscitation Device at 0 and 7 Weeks Follow up.

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.

Study Overview

• Status: Completed
• Conditions: Infant Showing No Response to Resuscitation
• Intervention / Treatment: Device: MedNav

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Previous Neonatal training,

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: MedNav; MedNav is a tablet based platform that uses auditory and visual cues to prompt people to perform the correct steps in neonatal resuscitation.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to perform Neonatal Resuscitation on a mannequin immediately and at 7 weeks following teaching.	Neonatal resuscitation will be assessed as defined by task completion based on an assessment sheet adapted from the resuscitation councils NLS course assessment.	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confidence in performing neonatal resuscitation	Confidence as marked on a 7 point Likert scale	0 weeks and 7 weeks post teaching

Collaborators and Investigators

• Sponsor: Chelsea and Westminster NHS Foundation Trust
• Investigators: Study Director: Shane P Duffy, MBChB, Chelsea and Westminster Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Education; Neonatal; Resuscitation
• Other Study ID Numbers: ChelseaNHS

Plan for Individual participant data (IPD)

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