Infant Showing No Response to Resuscitation Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02181894 -
Identifying the Most Accurate Method for Predicting the Safe Depth of Orally Placed Neonatal Endotracheal Tubes (ETT).
|