Global HealthNCT05278884
Can VAST Improve ACLS in Rwanda
A study testing Advanced Cardiac Life Support Training and Vital Anesthesia Simulation Training in people with Global Health and Education, run by University of Toronto at 1 site in Rwanda.
Trial summary
Aim The purpose of this study is to determine if the addition of the VAST Course to technical resuscitation skills training enhances healthcare providers' resuscitation performance in a resource-limited setting. Objectives The aims of this research will be achieved by meeting the following objectives: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Global Health, Education, Resuscitation
- What is being tested?
- Advanced Cardiac Life Support Training and Vital Anesthesia Simulation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteRwanda
- Study dates
- 1 May 2022to 1 Oct 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Full course participation
- Available for focus group interviews
Who cannot join
- Refusal to provide informed consent
- Participated in VAST or ACLS training in the four months prior to study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the VAST Course Enhance Resuscitation Skills in a Resource-limited Setting?
Aim The purpose of this study is to determine if the addition of the VAST Course to technical resuscitation skills training enhances healthcare providers' resuscitation performance in a resource-limited setting.
Objectives
Read more
The aims of this research will be achieved by meeting the following objectives:
- Quantitative evaluation of study participants' resuscitation performance during a simulation scenario before ACLS course, immediately following ACLS course, immediately following VAST course, and at 4 months post training.
- Qualitative exploration of the barriers and supports identified by course participants to implementing resuscitation in the workplace after resuscitation skills training through focus groups.
New knowledge Lessons learned from this study will help inform the design and the implementation of resuscitation training programs in resource-limited settings. This has potential to improve resuscitation capacity in resource-limited settings leading to higher quality of care for patients.
- Conditions
- Global Health, Education, Resuscitation
- Being tested
- Advanced Cardiac Life Support Training, Vital Anesthesia Simulation Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Cardiac Life Support TrainingBehavioural
Advanced Cardiovascular Life Support (ACLS) is a resuscitation course to teach recognition and treatment of cardiopulmonary arrest in patients.
Vital Anesthesia Simulation TrainingBehavioural
The Vital Anesthesia Simulation Training (VAST) Course focuses on core clinical practices and non-technical skills needed to respond to the most common urgent and emergent clinical challenges found in hospitals in resource-limited settings like Rwanda.
| Study group | Role | What they receive |
|---|---|---|
| ACLS and then VAST teaching intervention | Experimental | For each hospital, the intervention will be to pair a 2-day technical resuscitation skills training adapted from the ACLS/AHA and a 3-day VAST course for a multidisciplinary team of 20 participants (i.e., nurses, doctors, non-physician anesthesia providers). Participants' resuscitation skills will be tested at 4 time points: immediately before the ACLS course, immediately after the ACLS course, immediately after the VAST Course, and at 4 months post training. Receives: Behavioral: Advanced Cardiac Life Support Training; Behavioral: Vital Anesthesia Simulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initiation of CPR
The time it takes for the team to start chest compressions in the simulation in seconds
Measured: From start of simulation scenario to time of first chest compressions, assessment up to 2 minutes of simulation
Secondary outcomes (2)
Time to epinephrine administration
The time it takes for the team to give epinephrine in the simulation in seconds
Measured: From start of simulation scenario to time of first epinephrine administration, assessment up to 5 minutes of simulation
Time to defibrillation
The time it takes for the team to defibrillate in the simulation in seconds
Measured: From start of simulation scenario to time of first defibrillation, assessment up to 5 minutes of simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 May 2022
- Primary completion1 Jul 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Global HealthStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- For each hospital, the intervention will be to pair a 2-day technical resuscitation skills training adapted from the ACLS/AHA and a 3-day VAST course for a multidisciplinary team of 20 participants (i.e., nurses, doctors, non-physician anesthesia providers). Participants' resuscitation skills will be tested at 4 time points: immediately before the ACLS course, immediately after the ACLS course, immediately after the VAST Course, and at 4 months post training.
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rwanda, ANZCA Health Equity Project
- Responsible party
- Principal investigator, Teresa Skelton, University of Toronto
- Investigators
- Teresa Skelton, MD, FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278884
- Sponsor's protocol ID
- TSkelton
- Status last verified
- Nov 2022
- First submitted
- 28 Feb 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Final results will be prepared for publication but no plan to share IPD
Publications
Tuyishime E, Mossenson A, Livingston P, Irakoze A, Seneza C, Ndekezi JK, Skelton T. Resuscitation team training in Rwanda: A mixed method study exploring the combination of the VAST course with Advanced Cardiac Life Support training. Resusc Plus. 2023 Jun 16;15:100415. doi: 10.1016/j.resplu.2023.100415. eCollection 2023 Sep.
PubMed 37363124
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the VAST Course Enhance Resuscitation Skills in a Resource-limited Setting?
- ClinicalTrials.gov ID
- NCT05278884
- Acronym / sponsor ID
- TSkelton
- Conditions
- Global Health, Education, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University of Rwanda, ANZCA Health Equity Project
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 14 Mar 2022 (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.
Aim The purpose of this study is to determine if the addition of the VAST Course to technical resuscitation skills training enhances healthcare providers' resuscitation performance in a resource-limited setting.
Objectives
The aims of this research will be achieved by meeting the following objectives:
- Quantitative evaluation of study participants' resuscitation performance during a simulation scenario before ACLS course, immediately following ACLS course, immediately following VAST course, and at 4 months post training.
- Qualitative exploration of the barriers and supports identified by course participants to implementing resuscitation in the workplace after resuscitation skills training through focus groups.
New knowledge Lessons learned from this study will help inform the design and the implementation of resuscitation training programs in resource-limited settings. This has potential to improve resuscitation capacity in resource-limited settings leading to higher quality of care for patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For each hospital, the intervention will be to pair a 2-day technical resuscitation skills training adapted from the ACLS/AHA and a 3-day VAST course for a multidisciplinary team of 20 participants (i.e., nurses, doctors, non-physician anesthesia providers). Participants' resuscitation skills will be tested at 4 time points: immediately before the ACLS course, immediately after the ACLS course, immediately after the VAST Course, and at 4 months post training.
| Arm | Type | Receives |
|---|---|---|
| ACLS and then VAST teaching intervention | Experimental | Behavioral: Advanced Cardiac Life Support Training, Behavioral: Vital Anesthesia Simulation TrainingFor each hospital, the intervention will be to pair a 2-day technical resuscitation skills training adapted from the ACLS/AHA and a 3-day VAST course for a multidisciplinary team of 20 participants (i.e., nurses, doctors, non-physician anesthesia providers). Participants' resuscitation skills will be tested at 4 time points: immediately before the ACLS course, immediately after the ACLS course, immediately after the VAST Course, and at 4 months post training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Full course participation
- Available for focus group interviews
Key exclusion criteria (2 listed)
- Refusal to provide informed consent
- Participated in VAST or ACLS training in the four months prior to study
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 |
|---|---|---|
| Advanced Cardiac Life Support TrainingAdvanced Cardiovascular Life Support (ACLS) is a resuscitation course to teach recognition and treatment of cardiopulmonary arrest in patients. | Behavioural | ACLS and then VAST teaching intervention |
| Vital Anesthesia Simulation TrainingThe Vital Anesthesia Simulation Training (VAST) Course focuses on core clinical practices and non-technical skills needed to respond to the most common urgent and emergent clinical challenges found in hospitals in resource-limited settings like Rwanda. | Behavioural | ACLS and then VAST teaching intervention |
Primary outcome
Time to initiation of CPR
Time frame: From start of simulation scenario to time of first chest compressions, assessment up to 2 minutes of simulation
The time it takes for the team to start chest compressions in the simulation in seconds
2 secondary outcomes
Time to epinephrine administration
Time frame: From start of simulation scenario to time of first epinephrine administration, assessment up to 5 minutes of simulation
Time to defibrillation
Time frame: From start of simulation scenario to time of first defibrillation, assessment up to 5 minutes of simulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Derived from this study: PubMed 37363124Tuyishime E, Mossenson A, Livingston P, Irakoze A, Seneza C, Ndekezi JK, Skelton T. Resuscitation team training in Rwanda: A mixed method study exploring the combination of the VAST course with Advanced Cardiac Life Support training. Resusc Plus. 2023 Jun 16;15:100415. doi: 10.1016/j.resplu.2023.100415. eCollection 2023 Sep.
- Individual participant dataSharing planned: No. Final results will be prepared for publication but no plan to share IPD
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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.
Teresa Skelton, MD, FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Cardiac Life Support Training and Vital Anesthesia Simulation Training in people with Global Health and Education, run by University of Toronto at 1 site in Rwanda.
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 2 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: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to initiation of CPR (time frame: From start of simulation scenario to time of first chest compressions, assessment up to 2 minutes of simulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05278884, which also lists 1 linked publication.
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 Nov 2022.