PediAppRREST - Effectiveness of an Interactive Cognitive Support Tablet App in Reducing Deviations From Guidelines in the Management of Pediatric Cardiac Arrest: a Simulation-based Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 4
- 主要终点
- Deviations from American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines
研究概览
简要总结
Pediatric cardiac arrest (PCA) has a high mortality and morbidity. Its management is complex and often deviates from guideline recommendations leading to patients' worse clinical outcomes. A new tablet app, named PediAppRREST has been developed by our research group to support the management of PCA. The aim of the study is to evaluate the impact of the PediAppRREST app on the management of a PCA simulated scenario. The investigators have planned to conduct a multicenter, simulation-based, randomized control trial assessing the number of deviations (errors and delays) from international recommendations in PCA management. The hypothesis is that teams who use the PediAppRREST app as a cognitive aid will show fewer deviations from guidelines than teams who use a static paper-based cognitive aid (American Heart Association Pediatric Advanced Life Support pocket reference card) or no cognitive aid, during the management of a simulated PCA scenario.
详细描述
AIMS
The primary aim of the study is to evaluate the effectiveness of a new tablet app, named PediAppRREST, in reducing deviations from guideline recommendations during pediatric cardiac arrest management.
The secondary aim is to assess the impact of the use of the app on performance and time to accomplish critical interventions for resuscitation, team leader's workload, cardiopulmonary resuscitation quality metrics and overall resuscitation team performance. Furthermore, the study will have the purpose to evaluate the usability of the app.
METHODS
PARTICIPANTS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of this study, blinding of the participants, investigators and outcome assessors will not be possible. However, data analyses will be performed by a statistician who will be blinded to the allocation arm (PediAppRREST tablet app, PALS pocket reference card, no cognitive aid).
入排标准
- 年龄范围
- 24 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •to be attending a medical residency training program in Pediatrics, Anesthesiology-Intensive Care or Emergency Medicine
- •to be BLS (Basic Life Support) or P-BLS (Pediatric-Basic Life Support) or PALS (Pediatric Advanced Life Suport) or ALS (Advanced Life Support) or ACLS (Advanced Cardiac Life Support) certified, following the American Heart Association (AHA) or the European Resuscitation Council (ERC) courses
- •to give consent to participate to the study and to be video-recorded.
- •Additionally, to be eligible for the role of team leader, residents must be PALS-certified according to AHA or ERC guidelines
排除标准
- •to be unable to attend the simulation sessions because of personal leave, maternity/paternity leave, sick leave or training abroad
- •participation in previous studies using the PediAppRREST app
结局指标
主要结局
Deviations from American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines
时间窗: Scenario will be video recorded and evaluated by two independent video reviewers. Outcome assessors will score teams' performance by means of the c-DEV15plus score using data extracted by video reviewers through study completion, an average of 15 months.
Deviations from AHA-PALS guidelines recommendations are defined as delays and errors according to a novel checklist we derived from a previously published checklist, denominated c-DEV (circulation-deviations), published by Wolfe et al. (2020), by integrating it with evidence-based guidelines, previously reported scoring tools and checklists. We named our new modified checklist c-DEV15plus (circulation-deviations 15 plus). It includes 15 items, which represent correct critical actions for pediatric resuscitation. Each item of the c-DEV15plus is scored either as 0, when the action is performed correctly and timely, as described in the item, or as 1, when the action is not undertaken, undertaken incorrectly, or with wrong timing. The sum of the points attributed to the items represents the c-DEV15plus total score, hence ranging from a minimum of 0 to a maximum of 15, with higher scores corresponding to a higher number of deviations from the guidelines and a worse performance.
次要结局
- Time to cardiac arrest (pulsenessness) recognition(Scenario will be video recorded and successively two independent video reviewers will assess the time to pulselessness recognition, through study completion, an average of 15 months.)
- Performance of ventilation(Scenario will be video recorded and successively two independent video reviewers will assess the start of ventilation, through study completion, an average of 15 months.)
- Time to call for emergency team help from the beginning of the scenario(Scenario will be video recorded and successively two independent video reviewers will assess the time to call for emergency team help, through study completion, an average of 15 months.)
- Time to start electrocardiogram monitoring from arrest recognition(Scenario will be video recorded and successively two independent video reviewers will assess the time to start electrocardiogram monitoring, through study completion, an average of 15 months.)
- Time to start chest compressions from arrest recognition(Scenario will be video recorded and successively two independent video reviewers will assess the time to start chest compressions, through study completion, an average of 15 months.)
- Time to start chest compressions from the beginning of the scenario(Scenario will be video recorded and successively two independent video reviewers will assess the time to start chest compressions, through study completion, an average of 15 months.)
- Use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin(Scenario will be video recorded and successively two independent video reviewers will assess the use of a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.)
- Time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin from the beginning of the scenario(Scenario will be video recorded and successively two independent video reviewers will assess the time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.)
- Call for emergency team help(Scenario will be video recorded and successively two independent video reviewers will assess the call for emergency team help, through study completion, an average of 15 months.)
- Time to start electrocardiogram monitoring from the beginning of scenario(Scenario will be video recorded and successively two independent video reviewers will assess the time to start electrocardiogram monitoring, through study completion, an average of 15 months.)
- Administration of a correct first epinephrine(Scenario will be video recorded and successively two independent video reviewers will assess the correct administration of the first epinephrine, through study completion, an average of 15 months.)
- Time to second epinephrine administration from the beginning of the scenario(Scenario will be video recorded and successively two independent video reviewers will assess the time to second epinephrine administration, through study completion, an average of 15 months.)
- Recognition of cardiac arrest (pulsenessness)(Scenario will be video recorded and successively two independent video reviewers will assess the pulsessness recognition, through study completion, an average of 15 months.)
- Time to start of ventilation from arrest recognition(Scenario will be video recorded and successively two independent video reviewers will assess the time to start ventilation, through study completion, an average of 15 months.)
- Administration of a correct second epinephrine(Scenario will be video recorded and successively two independent video reviewers will assess the correct administration of the second epinephrine dose, through study completion, an average of 15 months.)
- Usability of the app - Open-ended questions(Questionnaires will be completed after each simulated scenario through study completion, an average of 15 months.)
- Performance of chest compressions(Scenario will be video recorded and successively two independent video reviewers will assess the performance of chest compressions, through study completion, an average of 15 months.)
- Time to start of ventilation from the beginning of the scenario(Scenario will be video recorded and successively two independent video reviewers will assess the time to start ventilation, through study completion, an average of 15 months.)
- Time to call for emergency team help from arrest recognition(Scenario will be video recorded and successively two independent video reviewers will assess the time to call for emergency team help, through study completion, an average of 15 months.)
- Use of electrocardiogram monitoring(Scenario will be video recorded and successively two independent video reviewers will assess the use of electrocardiogram monitoring, through study completion, an average of 15 months.)
- Time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin from arrest recognition(Scenario will be video recorded and successively two independent video reviewers will assess the time to use a cardiopulmonary resuscitation board or a rigid surface underneath the manikin, through study completion, an average of 15 months.)
- Time to first epinephrine administration from arrest recognition(Scenario will be video recorded and successively two independent video reviewers will assess the time to the first epinephrine administration, through study completion, an average of 15 months.)
- Time to first epinephrine administration from the beginning of the scenario(Scenario will be video recorded and successively two independent video reviewers will assess the time to the first epinephrine administration, through study completion, an average of 15 months.)
- Time to second epinephrine administration from arrest recognition(Scenario will be video recorded and successively two independent video reviewers will assess the time to second epinephrine administration, through study completion, an average of 15 months.)
- Treatment of reversible causes(Scenario will be video recorded and successively two independent video reviewers will assess the correct treatment of reversible causes, through study completion, an average of 15 months.)
- Time to treatment of reversible causes from arrest recognition(Scenario will be video recorded and successively two independent video reviewers will assess the time to treatment of reversible causes, through study completion, an average of 15 months.)
- Usability of the app - System Usability Scale(Questionnaires will be completed after each simulated scenario through study completion, an average of 15 months.)
- Cardiopulmonary resuscitation (CPR) quality metrics - Chest compressions fraction(CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.)
- Time to treatment of reversible causes from the beginning of the scenario(Scenario will be video recorded and successively two independent video reviewers will assess the time to treatment of reversible causes, through study completion, an average of 15 months.)
- Team leaders' workload(Questionnaires will be completed by team leaders after each simulated scenario through study completion, an average of 15 months.)
- Cardiopulmonary resuscitation (CPR) quality metrics - Mean chest compression depth(CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.)
- Cardiopulmonary resuscitation (CPR) quality - Mean chest compression rate(CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.)
- Cardiopulmonary resuscitation (CPR) quality metrics - Compression depth correctness(CPR quality data will be extracted by the manikin's software after each simulated scenario, through study completion, an average of 15 months.)
- Team resuscitation performance(Scenario will be video recorded and successively evaluated by two independent video reviewers. Outcome assessors will score teams' performance by means of CPT using data extracted by video reviewers, through study completion, an average of 15 months.)
研究者
Silvia Bressan
Assistant professor, Attending Physician in Pediatric Emergency Medicine, MD, PhD.
University of Padova