Ventilation Skills Acquisition and RetentionSim-IINCT04889001
Ventilation Knowledge and Skills Retention Using a Novel Tool, the Augmented Infant Resuscitator (AIR) Device as an Instant-feedback Tool
A study testing Simulation enhanced HBB training in people with Ventilation Skills Acquisition and Retention and Ventilation Knowledge Acquisition and Retention, run by Mbarara University of Science and Technology.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilation Skills Acquisition and Retention, Ventilation Knowledge Acquisition and Retention
- What is being tested?
- Simulation enhanced HBB training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medicine students
- Nursing students
- Midwifery students
- Students at Mbarara University, Busitema University, Lira University, University of Jos
Who cannot join
- Students outside the participating institutions
- Students outside the Faculty of Medicine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ventilation Knowledge and Skills Retention Among Medical, Nursing and Midwifery Students Using a Novel Tool, the Augmented Infant Resuscitator (AIR) Device as an Instant-feedback Tool / "Electronic Coach".
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.
Read the 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
- Being tested
- Simulation enhanced HBB training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation enhanced HBB trainingOther
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 group | Role | What they receive |
|---|---|---|
| Before/After | Other | Before and after comparison- one arm study Receives: Other: Simulation enhanced HBB training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation skills
Retention of ventilation skills measured using Helping babies breathe Objective Structured Clinical Examinations (OSCE)
Measured: 12 months from baseline, after the training program
Time to effective ventilation
Time in seconds to effective ventilation
Measured: 12 months from baseline, after the training program
Duration of effective ventilation
Time in seconds for the duration of effective ventilation
Measured: 12 months from baseline, after the training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation Skills Acquisition and RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, The ELMA Foundation, Alberta Children's Hospital Research Institute, Laerdal Foundation, International Development Research Centre, Canada
- Responsible party
- Sponsor
- Investigators
- Data Santorino, MD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889001
- Sponsor's protocol ID
- 2020/MUST-4/SIM-II
- Acronym
- Sim-II
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data involves sensitive information such as video recordings and will therefore not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation Knowledge and Skills Retention Among Medical, Nursing and Midwifery Students Using a Novel Tool, the Augmented Infant Resuscitator (AIR) Device as an Instant-feedback Tool / "Electronic Coach".
- ClinicalTrials.gov ID
- NCT04889001
- Acronym / sponsor ID
- Sim-II / 2020/MUST-4/SIM-II
- Conditions
- Ventilation Skills Acquisition and Retention, Ventilation Knowledge Acquisition and Retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Calgary, The ELMA Foundation, Alberta Children's Hospital Research Institute, Laerdal Foundation, International Development Research Centre, Canada
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Before/After | Other | Other: Simulation enhanced HBB trainingBefore and after comparison- one arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Medicine students
- Nursing students
- Midwifery students
- Students at Mbarara University, Busitema University, Lira University, University of Jos
Key exclusion criteria (2 listed)
- Students outside the participating institutions
- Students outside the Faculty of Medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation enhanced HBB trainingSimulation 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. | Other | Before/After |
Primary outcome
Ventilation skills
Time frame: 12 months from baseline, after the training program
Retention of ventilation skills measured using Helping babies breathe Objective Structured Clinical Examinations (OSCE)
Time to effective ventilation
Time frame: 12 months from baseline, after the training program
Time in seconds to effective ventilation
Duration of effective ventilation
Time frame: 12 months from baseline, after the training program
Time in seconds for the duration of effective ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Individual participant dataSharing planned: No. The data involves sensitive information such as video recordings and will therefore not be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Data Santorino, MD principal investigator
Mbarara University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Simulation enhanced HBB training in people with Ventilation Skills Acquisition and Retention and Ventilation Knowledge Acquisition and Retention, run by Mbarara University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Data Santorino, MD (0774500571, sdata@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation skills (time frame: 12 months from baseline, after the training program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.