Cardiopulmonary ResuscitationNCT06341218
The Effect Of Simulation-Supported Pediatric CPR Training Based On CRM On Knowledge, Attitude, And Performance
A study testing Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource Management in people with Cardiopulmonary Resuscitation, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
Crew Resource Management is a training system that aims to use all available resources effectively and increase safety by improving technical knowledge and skills as well as non-technical skills in risky tasks such as CPR. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2021to 15 Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Working in Ege University Pediatric Intensive Care Unit or Pediatric Emergency Service
- Voluntary acceptance to participate in the study
- Participated in CPR case management at least once
- Not having received ECM training before
- Not having received any training on Pediatric CPR and ECPR during the implementation phase of the study
Who cannot join
- Voluntary refusal to participate in the study,
- Never participated in CPR case management,
- Having received EKY training before,
- Having received any training in Paediatric CPR and ECM during the implementation phase of the study,
- Incomplete completion of the data collection tools of the study or failure to complete the simulation phase
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Simulation-Supported Pediatric Cardiopulmonary Resuscitation Training Based On Crew Resource Management On Knowledge, Attitude, And Performance
Crew Resource Management is a training system that aims to use all available resources effectively and increase safety by improving technical knowledge and skills as well as non-technical skills in risky tasks such as CPR. In safe critical patient management, the healthcare team should have interpersonal skills such as communication, stress management, teamwork, and leadership, cognitive skills such as situational awareness, task completion, planning, monitoring the situation, and rapid response to critical incidents, in addition to technical skills. To improve outcomes after pediatric cardiac arrest, many systems have been developed for performance measurement and quality improvement initiatives of the healthcare team. However, studies are needed to evaluate the effects of these systems. This study was planned to evaluate the effectiveness of simulation-supported pediatric cardiopulmonary resuscitation training based on team resource management on knowledge, attitude, and performance of the healthcare team in the pediatric intensive care unit.
Read the detailed description
The study was conducted to evaluate the effectiveness of simulation-supported pediatric cardiopulmonary resuscitation training based on the principles of Team Resource Management (ERM) on the knowledge, attitude, and performance of the healthcare team in the pediatric intensive care unit.
In this prospective randomized controlled study, nurses and physician assistants working in the Pediatric Intensive Care Unit (n=35), determined as the intervention group, and in the Pediatric Emergency Department (n=35), which was determined as the control group, were included in the sample. The intervention group received EKY-based pediatric CPR training, and it was assumed that the control group knew pediatric CPR management by their clinical duties. All CPR teams in the intervention and control groups were simulated with pediatric cardiac arrest scenarios and their pediatric CPR knowledge, attitudes, and performance were examined.While forming the intervention and control groups, stratified random sampling was performed by targeting the years of pediatric professional experience of resident physicians and nurses, and homogeneity between the groups was ensured.
The intervention group received CRM based pediatric CPR training and the control group was assumed to know pediatric CPR management as per their clinical duties. 'Healthcare Team Socio-Demographic Data Collection Form', 'Pediatric CPR Information Form', 'Teamwork Attitudes Scale', 'Pediatric CPR Team Performance Checklist', 'Student Satisfaction in Learning and Self-Confidence Scale' was used to collect the data for the study.
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource Management
- Keywords
- crew resource management, cpr, multidisciplinary health team, pediatric nursing, patient simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource ManagementOther
The sociodemographic information form, Pediatric CPR knowledge level and teamwork attitudes pretest were administered to the healthcare teams just before the training intervention.
The intervention group received a 3-hour training intervention on technical/non-technical skills for CRM-Based Pediatric CPR Training To measure pediatric CPR team performance, 5 different scenarios were prepared by the researcher by INACLS standards. One day after the training intervention, simulation application including pediatric cardiac arrest scenarios was applied to all CPR teams in the intervention(5 groups) and control(5 groups) groups. The scenario content was based on a 5-year-old male patient diagnosed with Pneumonia+Septic Shock.
Pediatric CPR skill levels of the healthcare teams were evaluated during the simulation practice. Immediately after the simulation, the post-intervention post-test of Pediatric CPR knowledge level and team attitudes of the healthcare teams was performed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The intervention group was divided into 5 CPR teams consisting of 5 nurses and 2 physician assistants. While forming the intervention group, stratified random sampling was performed by targeting the years of professional experience of assistant physicians and nurses and homogeneity between subgroups was ensured. CRM-Based Pediatric CPR Training was given to the intervention group. Receives: Other: Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource Management |
| Control Group | No intervention | The Control group was divided into 5 CPR teams consisting of 5 nurses and 2 physician assistants. While forming the control group, stratified random sampling was performed by targeting the years of professional experience of assistant physicians and nurses, and homogeneity between subgroups was ensured. The control group was assumed to know pediatric CPR management as per their clinical duties and no educational intervention was made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-demographic data of the healthcare team
In this form, there are closed-ended questions about the participant's age, gender, occupation, educational status, duration of professional experience, area of professional experience, the status of receiving Pediatric CPR training in undergraduate education, the status of attending the Pediatric CPR Course, and the status of participating in CPR case management in the clinic.
In addition, open-ended questions were included to evaluate the reasons for the difficulties experienced in the management of the CPR process, the perception of a functional team in CPR management, the status of providing functional teamwork in risky tasks such as CPR in their clinics, and what are the individual-clinical-organizational suggestions to improve ECM management in the CPR process.
Measured: Baseline
Pediatric KPR knowledge level
The effect of simulation-supported pediatric KPR training based on team resource management on knowledge
The form includes a total of 25 statements, including 13 true and 12 false statements for the management of the Pediatric CPR process. A cut-off point of 80 points was set for the participants to be evaluated as successful in the form in which the level of knowledge of the participants was determined. For each statement in the form, the participants were expected to answer as 'True' - 'False' - 'No Idea'; each item was evaluated over 4 points.
Measured: 2 month
Pediatric KPR team attitude level
The effect of simulation-supported pediatric KPR training based on team resource management on team attitude
The Teamwork Attitudes Scale includes 5 sub-dimensions (team structure, leadership, situation monitoring, mutual support, and communication) and 28 items. The scale is a 5-point Likert-type scale (Strongly Disagree=1 point, Disagree=2 points, Undecided=3 points, Agree=4 points, Strongly Agree=5 points). As a result of the evaluation of the scale total score averages and sub-dimension score averages, the highest score is 140 and the lowest score is 28. As a result of the evaluation of the scale, the high score of the individual shows that the teamwork attitude is positive.
Measured: 2 month
Pediatric KPR team performance level
The effect of simulation-supported pediatric KPR training based on team resource management on performance
Pediatric CPR Team Performance Checklist; while the participant performed the skill expected from him/her in the simulation environment, the researcher monitored how this skill was performed and evaluated through pre-structured and progressive checklists. In the evaluation of the Pediatric CPR Team Performance Checklist; according to the performance of the participant, each item was evaluated as 'Not Performed=0 points', 'Partially Performed=1 point', and 'Performed=2 points'. Total score averages were used in the evaluation. The Pediatric CPR Team Performance Checklist includes the following sections; Phase 1: Pre-CPR Performance Checklist (16 items) Phase 2: CPR Process Performance Checklist (16 items) Phase 3: Post-KPR Performance Checklist (6 items) Phase 4: CPR Process Non-Technical Skills Checklist (13 items)
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start25 Feb 2021
- Primary completion30 Sep 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Signem ANOL KILIÇ, Zonguldak Bulent Ecevit University
- Investigators
- SİĞNEM ANOL KILIÇ, PhD, Principal investigator, Research assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341218
- Sponsor's protocol ID
- 21-5T/3
- Status last verified
- Apr 2024
- First submitted
- 28 Nov 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Simulation-Supported Pediatric Cardiopulmonary Resuscitation Training Based On Crew Resource Management On Knowledge, Attitude, And Performance
- ClinicalTrials.gov ID
- NCT06341218
- Acronym / sponsor ID
- 21-5T/3
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- crew resource management, cpr, multidisciplinary health team, pediatric nursing, patient simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 2 Apr 2024 (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.
Crew Resource Management is a training system that aims to use all available resources effectively and increase safety by improving technical knowledge and skills as well as non-technical skills in risky tasks such as CPR. In safe critical patient management, the healthcare team should have interpersonal skills such as communication, stress management, teamwork, and leadership, cognitive skills such as situational awareness, task completion, planning, monitoring the situation, and rapid response to critical incidents, in addition to technical skills. To improve outcomes after pediatric cardiac arrest, many systems have been developed for performance measurement and quality improvement initiatives of the healthcare team. However, studies are needed to evaluate the effects of these systems. This study was planned to evaluate the effectiveness of simulation-supported pediatric cardiopulmonary resuscitation training based on team resource management on knowledge, attitude, and performance of the healthcare team in the pediatric intensive care unit.
Detailed description
The study was conducted to evaluate the effectiveness of simulation-supported pediatric cardiopulmonary resuscitation training based on the principles of Team Resource Management (ERM) on the knowledge, attitude, and performance of the healthcare team in the pediatric intensive care unit.
In this prospective randomized controlled study, nurses and physician assistants working in the Pediatric Intensive Care Unit (n=35), determined as the intervention group, and in the Pediatric Emergency Department (n=35), which was determined as the control group, were included in the sample. The intervention group received EKY-based pediatric CPR training, and it was assumed that the control group knew pediatric CPR management by their clinical duties. All CPR teams in the intervention and control groups were simulated with pediatric cardiac arrest scenarios and their pediatric CPR knowledge, attitudes, and performance were examined.While forming the intervention and control groups, stratified random sampling was performed by targeting the years of pediatric professional experience of resident physicians and nurses, and homogeneity between the groups was ensured.
The intervention group received CRM based pediatric CPR training and the control group was assumed to know pediatric CPR management as per their clinical duties. 'Healthcare Team Socio-Demographic Data Collection Form', 'Pediatric CPR Information Form', 'Teamwork Attitudes Scale', 'Pediatric CPR Team Performance Checklist', 'Student Satisfaction in Learning and Self-Confidence Scale' was used to collect the data for the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource ManagementThe intervention group was divided into 5 CPR teams consisting of 5 nurses and 2 physician assistants. While forming the intervention group, stratified random sampling was performed by targeting the years of professional experience of assistant physicians and nurses and homogeneity between subgroups was ensured. CRM-Based Pediatric CPR Training was given to the intervention group. |
| Control Group | No intervention | –The Control group was divided into 5 CPR teams consisting of 5 nurses and 2 physician assistants. While forming the control group, stratified random sampling was performed by targeting the years of professional experience of assistant physicians and nurses, and homogeneity between subgroups was ensured. The control group was assumed to know pediatric CPR management as per their clinical duties and no educational intervention was made. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Working in Ege University Pediatric Intensive Care Unit or Pediatric Emergency Service
- Voluntary acceptance to participate in the study
- Participated in CPR case management at least once
- Not having received ECM training before
- Not having received any training on Pediatric CPR and ECPR during the implementation phase of the study
Key exclusion criteria (5 listed)
- Voluntary refusal to participate in the study,
- Never participated in CPR case management,
- Having received EKY training before,
- Having received any training in Paediatric CPR and ECM during the implementation phase of the study,
- Incomplete completion of the data collection tools of the study or failure to complete the simulation phase
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 |
|---|---|---|
| Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource ManagementThe sociodemographic information form, Pediatric CPR knowledge level and teamwork attitudes pretest were administered to the healthcare teams just before the training intervention. The intervention group received a 3-hour training intervention on technical/non-technical skills for CRM-Based Pediatric CPR Training To measure pediatric CPR team performance, 5 different scenarios were prepared by the researcher by INACLS standards. One day after the training intervention, simulation application including pediatric cardiac arrest scenarios was applied to all CPR teams in the intervention(5 groups) and control(5 groups) groups. The scenario content was based on a 5-year-old male patient diagnosed with Pneumonia+Septic Shock. Pediatric CPR skill levels of the healthcare teams were evaluated during the simulation practice. Immediately after the simulation, the post-intervention post-test of Pediatric CPR knowledge level and team attitudes of the healthcare teams was performed. | Other | Intervention Group |
Primary outcome
Socio-demographic data of the healthcare team
Time frame: Baseline
In this form, there are closed-ended questions about the participant's age, gender, occupation, educational status, duration of professional experience, area of professional experience, the status of receiving Pediatric CPR training in undergraduate education, the status of attending the Pediatric CPR Course, and the status of participating in CPR case management in the clinic. In addition, open-ended questions were included to evaluate the reasons for the difficulties experienced in the management of the CPR process, the perception of a functional team in CPR management, the status of providing functional teamwork in risky tasks such as CPR in their clinics, and what are the individual-clinical-organizational suggestions to improve ECM management in the CPR process.
Pediatric KPR knowledge level
Time frame: 2 month
The effect of simulation-supported pediatric KPR training based on team resource management on knowledge The form includes a total of 25 statements, including 13 true and 12 false statements for the management of the Pediatric CPR process. A cut-off point of 80 points was set for the participants to be evaluated as successful in the form in which the level of knowledge of the participants was determined. For each statement in the form, the participants were expected to answer as 'True' - 'False' - 'No Idea'; each item was evaluated over 4 points.
Pediatric KPR team attitude level
Time frame: 2 month
The effect of simulation-supported pediatric KPR training based on team resource management on team attitude The Teamwork Attitudes Scale includes 5 sub-dimensions (team structure, leadership, situation monitoring, mutual support, and communication) and 28 items. The scale is a 5-point Likert-type scale (Strongly Disagree=1 point, Disagree=2 points, Undecided=3 points, Agree=4 points, Strongly Agree=5 points). As a result of the evaluation of the scale total score averages and sub-dimension score averages, the highest score is 140 and the lowest score is 28. As a result of the evaluation of the scale, the high score of the individual shows that the teamwork attitude is positive.
Pediatric KPR team performance level
Time frame: 2 month
The effect of simulation-supported pediatric KPR training based on team resource management on performance Pediatric CPR Team Performance Checklist; while the participant performed the skill expected from him/her in the simulation environment, the researcher monitored how this skill was performed and evaluated through pre-structured and progressive checklists. In the evaluation of the Pediatric CPR Team Performance Checklist; according to the performance of the participant, each item was evaluated as 'Not Performed=0 points', 'Partially Performed=1 point', and 'Performed=2 points'. Total score averages were used in the evaluation. The Pediatric CPR Team Performance Checklist includes the following sections; Phase 1: Pre-CPR Performance Checklist (16 items) Phase 2: CPR Process Performance Checklist (16 items) Phase 3: Post-KPR Performance Checklist (6 items) Phase 4: CPR Process Non-Technical Skills Checklist (13 items)
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 2 Apr 2024.
Related trials for Cardiopulmonary Resuscitation
Active, not recruiting
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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
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Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
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The OXY-VENT Study
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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.
SİĞNEM ANOL KILIÇ, PhD principal investigator
Research assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource Management in people with Cardiopulmonary Resuscitation, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 2 Apr 2024. 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 Turkey (Türkiye). 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?
Socio-demographic data of the healthcare team (time frame: Baseline). The study lists 4 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 2 Apr 2024.