Ventilation Knowledge and Skills Retention Using a Novel Tool, the Augmented Infant Resuscitator (AIR) Device as an Instant-feedback Tool

NCT04889001 | Unknown

• 1 other identifier: 2020/MUST-4/SIM-II
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Babies born not breathing at birth require effective gentle ventilation to survive and avert organ damage if initial resuscitation steps such as drying, and stimulation are unsuccessful at facilitating breathing. Training of health workers to impart skills on ventilation is a way to prevent these adverse outcomes. Effective ventilation skills are typically acquired through training programs such as Helping Babies Breath (HBB). However, these ventilation skills quickly decay following training and current skills retention methods such as refresher courses are costly and there is a paucity of skilled human resources to effectively facilitate frequent HBB training courses. This raises the need to explore approaches that are independent of retraining for skills maintenance. The investigators hypothesize that simulation enhanced HBB training followed by self-administered ventilation practice (SAVP) sessions with the Augmented Infant Resuscitator (AIR) as an electronic coach will result into ventilation skills retention over 12 months. SAVP allows participants to maintain practice and training to enhance skills retention.

Conditions

Ventilation Skills Acquisition and Retention; Ventilation Knowledge Acquisition and Retention

Outcome Measures

Primary Outcomes (3)

• Ventilation skills

  Retention of ventilation skills measured using Helping babies breathe Objective Structured Clinical Examinations (OSCE)

  12 months from baseline, after the training program

• Time to effective ventilation

  Time in seconds to effective ventilation

  12 months from baseline, after the training program

• Duration of effective ventilation

  Time in seconds for the duration of effective ventilation

  12 months from baseline, after the training program

Study Arms (1)

Before/After

OTHER

Before and after comparison- one arm study

Other: Simulation enhanced HBB training

Interventions

Simulation enhanced HBB training OTHER

Simulation enhanced HBB is a one-day course delivered using a format of Explain, Demonstrate and Facilitate practice. Compared to the standard HBB training, the simulation enhanced HBB course is designed with increased peer-to-peer feedback and scripted expert facilitator feedback at HBB practice exercises.

Before/After

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medicine students
• Nursing students
• Midwifery students
• Students at Mbarara University, Busitema University, Lira University, University of Jos

You may not qualify if:

• Students outside the participating institutions
• Students outside the Faculty of Medicine

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead
• University of Calgary: collaborator
• The ELMA Foundation: collaborator
• Alberta Children's Hospital Research Institute: collaborator
• Laerdal Foundation: collaborator
• International Development Research Centre, Canada: collaborator

Study Officials

• Data Santorino, MD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Data Santorino, MD

CONTACT

0774500571; sdata@must.ac.ug

Francis Bajunirwe, MD, PhD

CONTACT

0772 576 396; fbaj@must.ac.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before and after intervention comparison. The students will be trained in simulation enhanced HBB. Simulation enhanced HBB is a one-day course delivered using a format of Explain, Demonstrate and Facilitate practice. Compared to the standard HBB training, the simulation enhanced HBB course is designed with increased peer-to-peer feedback and scripted expert facilitator feedback at HBB practice exercises.

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 17, 2021
• Study Start: October 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: May 17, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share