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

NCT ID: NCT04889001

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-12-30

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.

Detailed Description

The investigators will use a multi-methods approach. First, investigators will evaluate the effect of simulation enhanced HBB training and short self-administered practice with AIR device feedback on ventilation skills among undergraduate medical, nursing and midwifery students in Nigeria, Tanzania, and Uganda over a 12-month period. These short practice sessions will be conducted in skills labs. The investigators will equip each skills lab with at least 20 practice stations to enable increased number of students per unit time and reduce total required time in the skills labs for self-practice.

Second, the investigators will conduct focus group discussions with students before and after the intervention, to examine student experiences of simulation with SAVP vis-à-vis their expectations prior and post exposure.

Study design: This will be a 12-month cohort study among medical, nursing and midwifery students rotating in clinical disciplines. We will use a quasi-experimental design and measure ventilation skills before and after administration of a simulation enhanced HBB training plus SAVP with AIR as an intervention. The ventilation skills will also be measured prospectively every 4 months over a 12-month period in HBB scenario settings.

Conditions

Ventilation Skills Acquisition and Retention; Ventilation Knowledge Acquisition and Retention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Before/After

Before and after comparison- one arm study

Group Type: OTHER

Simulation enhanced HBB training

Intervention Type: 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.

Interventions

Simulation enhanced HBB training

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

The ELMA Foundation

OTHER

Sponsor Role: collaborator

Alberta Children's Hospital Research Institute

OTHER

Sponsor Role: collaborator

Laerdal Foundation

OTHER

Sponsor Role: collaborator

International Development Research Centre, Canada

OTHER_GOV

Sponsor Role: collaborator

Mbarara University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Data Santorino, MD

Role: PRINCIPAL_INVESTIGATOR

Mbarara University of Science and Technology

Central Contacts

Data Santorino, MD

Role: CONTACT

sdata@must.ac.ug

0774500571

Francis Bajunirwe, MD, PhD

Role: CONTACT

fbaj@must.ac.ug

0772 576 396

Other Identifiers

2020/MUST-4/SIM-II

Identifier Type: -

Identifier Source: org_study_id