Cardiopulmonary ArrestNCT03921346
Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR
A study testing Mobile device app (PedAMINES™) 1st drug, Mobile device app (PedAMINES™) 2nd drug and Mobile device app (PedAMINES™) 3rd drug in people with Cardiopulmonary Arrest and Resuscitation, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
Trial summary
The study investigators will recruit paramedics in many Emergency Medical Services (EMS) in Switzerland to prepare direct intravenous (IV) emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Arrest, Resuscitation, Pediatrics
- What is being tested?
- Mobile device app (PedAMINES™) 1st drug, Mobile device app (PedAMINES™) 2nd drug and Mobile device app (PedAMINES™) 3rd drug
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Sep 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- To be paramedic certified
- To know how to prepare direct IV drugs
- To have previously completed the 5-minute introductory course to the use of the app PedAMINES™ dispensed by the study investigators
- Participation agreement
Who cannot join
- To have at any time previously used the app PedAMINES™
- To have not undergone the 5-minute introductory course to the use of the app PedAMINES™
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva Emergency Medical Services (ACE Ambulances)
Geneva, 1205
About this study
Official title: A Mobile Device App to Reduce Prehospital Medication Errors and Time to Drug Preparation and Delivery by EMS During Simulated Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized, Controlled Trial
The study investigators will recruit paramedics in many Emergency Medical Services (EMS) in Switzerland to prepare direct intravenous (IV) emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario. According to randomization, each paramedic will be asked to prepare sequentially 4 IV emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of a mobile device app. This app is designed to support drug preparation at pediatric dosages. In a previous multicenter randomized trial with nurses, the investigators reported the ability of this app to significantly reduce in-hospital continuous infusion medication error rates and drug preparation time compared to conventional preparation methods during simulation-based resuscitations. In this trial, the aim was to assess this app during pediatric out-of-hospital cardiopulmonary resuscitation with paramedics.
Read the detailed description
Children represent a vulnerable population with specific medical needs compared to adults. Fast, accurate, and safe preparation and administration of IV drugs is both complex and time consuming in pediatric critical situations, such as cardiopulmonary resuscitation (CPR). Most drugs given IV to children are provided in vials originally prepared for the adult population, which leads to the need for a specific individual, weight-based drug dose calculation and preparation for each child that varies widely across age groups. This error-prone process and the lower dosing error tolerance of children place them at a high risk for life-threatening medication errors. Despite well equipped and staffed environments with numerous available safeguards, direct IV medication errors have been reported in up to 41% of cases during simulated in-hospital pediatric resuscitations, 65% of which were incorrect medication dosage, making it the most common error. The rate of errors is also important in the prehospital setting, occurring in more than 30% of all pediatric drugs administered. As paramedics have little exposure to critically ill children, they have limited opportunities to administer resuscitation drugs at pediatric doses and to train this skill.
Moreover, in resuscitation, time is inversely correlated to survival. During the first 15 min of in-hospital pediatric CPR, survival and favorable neurological outcome decrease linearly by 2,1% and 1,2% per min, respectively, and rely in part on drug preparation time either in- or out-of-hospital. Among non-shockable pediatric out-of-hospital cardiac arrests, each minute delay to epinephrine delivery is associated with 9% decrease in the odds of survival. Regrettably, in the prehospital setting, the majority of patients receive epinephrine more than 10 minutes after EMS arrival. The chain of survival therefore critically relies on early out-of-hospital CPR by EMS, and onsite administration of IV emergency drugs without delay before a rapid transfer to pediatric emergency departments and advanced care.
In a previous multicenter, randomized crossover trial, medication errors, time to drug preparation, and time to drug delivery for continuous infusions during simulation-based pediatric in-hospital postcardiac arrest scenarios were significantly reduced by using a mobile device app - the pediatric accurate medication in emergency situations (PedAMINES™) app - designed to help pediatric drug preparation.
The present multicenter trial aims to compare the impact of this app with conventional calculation methods for the preparation of direct IV drugs during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios. The investigators hypothesized that use of the app might extend and scale up the previous multicenter in-hospital observations by similarly reducing occurrence of medication errors and time to drug preparation and delivery when used by paramedics in out-of-hospital settings.
In this trial, the investigators will recruit paramedics in many EMS in Switzerland to prepare direct IV emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario with a high-fidelity WiFi manikin (Laerdal SimBaby). The scenario will take place out-of-hospital in a simulated children's room to increase realism.
On the day of participation after random allocation (1:1 allocation ratio), each participating paramedic will (1) complete a survey collecting data regarding their demographics, care training, and simulation and computer experience, (2) receive a standardized 5-min training session on how to use the app, and (3) be presented the simulation manikin characteristics. The paramedics will then be asked to perform a 20-min highly realistic pediatric CPR scenario on the high-fidelity manikin. Each paramedic will be asked to prepare sequentially 4 intravenous emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of the mobile app. The procedure is standardized across all sites to follow the same chronological progression and range of difficulty to ensure each participant is exposed to exactly the same case, with similar challenges in decision making and treatment preparation provided on the same manikin.
All the actions (i.e. primary and secondary outcomes) performed by the paramedics during the scenario will be automatically recorded and stored by the responsive simulator detectors, the app, and by several GoPro Hero 5 Black edition action video cameras worn by the paramedics and placed within the room.
The study will be carried out in accordance with the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH) guidelines and the Reporting Guidelines for Health Care Simulation Research.
This study aims to compare the impact of this app with conventional calculation methods for the preparation of direct IV drugs during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios, were paramedics are little exposed to pediatric CPRs. The investigators hypothesize that use of the app might extend and scale up their previous multicenter in-hospital observations by similarly reducing occurrence of medication errors and time to drug preparation and delivery when used by paramedics in out-of-hospital settings.
- Conditions
- Cardiopulmonary Arrest, Resuscitation, Pediatrics, Medication Errors, Emergency Medical Services
- Being tested
- Mobile device app (PedAMINES™) 1st drug, Mobile device app (PedAMINES™) 2nd drug, Mobile device app (PedAMINES™) 3rd drug, Mobile device app (PedAMINES™) 4th drug, Conventional method 1st drug
- Keywords
- Medication errors, Drugs, Pediatrics, Biomedical Technology, Mobile applications, Emergency Medical Services
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile device app (PedAMINES™) 1st drugDevice
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Mobile device app (PedAMINES™) 2nd drugDevice
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Mobile device app (PedAMINES™) 3rd drugDevice
To prepare 4 mL/kg dextrose 10%
Mobile device app (PedAMINES™) 4th drugDevice
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
Conventional method 1st drugDevice
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Conventional method 2nd drugDevice
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Conventional method 3rd drugDevice
To prepare 4 mL/kg dextrose 10%
Conventional method 4th drugDevice
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
| Study group | Role | What they receive |
|---|---|---|
| Arm A (mobile device app) | Experimental | Paramedics preparing drugs with the help of the mobile device app PedAMINES™.
Each paramedic will have to prepare sequentially 4 direct IV emergency drugs with the help of the mobile device app PedAMINES™. Receives: Device: Mobile device app (PedAMINES™) 1st drug; Device: Mobile device app (PedAMINES™) 2nd drug; Device: Mobile device app (PedAMINES™) 3rd drug; Device: Mobile device app (PedAMINES™) 4th drug |
| Arm B (conventional preparation method) | Active comparator | Paramedics preparing drugs with the help of conventional method.
Each paramedic will have to prepare sequentially 4 direct IV emergency drugs with the help of conventional method Receives: Device: Conventional method 1st drug; Device: Conventional method 2nd drug; Device: Conventional method 3rd drug; Device: Conventional method 4th drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication Dosage Errors
To measure in each allocation group the number and percentage of medication dosage containing errors that occur during the sequence from drug preparation to drug injection. We define an emergency medication dose administration error as a failure in drug preparation if at least one of the following errors is committed: a deviation in drug dose of more than 10% from the correct weight dose; inability to calculate drug dosage without guidance help from the paramedic investigator (LB) leading the resuscitation in the room; and/or (because of its clinical relevance) a deviation of more than 10% of the final administered concentration of sodium bicarbonate from the prescribed 4.2% concentration. These errors will be measured both as the percentage deviation from the amount of delivered drug compared with the correct weight dose as prescribed by the physician and the absolute deviations from that dose.
Measured: 20 minutes
Secondary outcomes (5)
Time to Drug Preparation and Time to Drug Delivery
Secondary outcome will be the elapsed time in seconds between the oral prescription by the physician and a) time to drug preparation completion and b) time to drug delivery by the participant.
Measured: 20 minutes
Type of Medication Errors
Incorrect preparations: a) drug dose deviation >10% from the correct dose prescribed by the physician, b) drug preparation necessitating assistance (i.e., inability for the nurse to prepare the prescribed drug without the help of a third party), and c) >10% deviation from the prescribed drug dose in the 4th drug concentration will be reported.
Measured: During each of the 4 drug preparations, an average of 20 minutes per drug preparation.
Perceived Stress
Participants' self-assessed psychological stress will be measured before and after the intervention (ie. drug preparation) using the Gauthier and Bouchard's French-Canadian adaptation of Spielberger's psychometric State-Trait Anxiety Inventory (STAI) Form Y-1 questionnaire. STAI ranges from 20 to 80, with higher scores being positively correlated with greater stress.
Perceived stress will also be assessed by self-assessment using a numerical 10-point Likert visual analogue scale (VAS). Values range from 1 (totally unstressed) to 10 (totally stressed) to avoid neutral answers.
The perceived stress before the preparation of the 4 drugs and after the preparation of the 4 drugs will be indicated for each study arm. In other words, the perceived stress will not be given for each of the 4 drugs individually, but as a single value before and a single value after the drug preparation, for both the STAI and the VAS.
Measured: At preintervention and postintervention, a total of 20 minutes will be used to complete the STAI questionnaire.
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
The participants' stress level will be assessed by measuring continuously their heart rate using a Polar A360 smartwatch on their wrist during the resuscitation scenario. Mean delta HR values (difference between HR peak values and baseline HR) will be obtained during some small segments of scenario and correlated to the scenario phases and the preparation methods used.
Measured: Baseline, recovery, and during each of the 4 drug preparations, a total of 20 minutes per participant will be used to continuously record heart rates on the smartwatch. Maximal HRpeak is the maximum HR across all preparations
Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Unified Theory of Acceptance and Use of Technology (UTAUT): a 52-item questionnaire distributed in 8 core constructs: 1) perceived usefulness (4 items), 2) perceived ease of use (4 items), 3) task-technology fit (4 items), 4) performance expectancy (3 items), 5) impact on image (2 items), 6) personal innovativeness (3 items), 7) acceptance (3 items), and 8) behavioral intention to use the technology (3 items). Each construct are based on a Likert-type 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). Increments are integers between 1 to 5. Min score per construct = 1, max score per construct = 5. The higher the score, the better the acceptance.
System Usability Score (SUS): Comprises a 10-item questionnaire with 5 response options for each item, ranging from 1 (strongly disagree) to 5 (strongly agree). The higher the score, the better the usability (ie, 0=very poor perceived usability and 100=excellent perceived usability)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start3 Sep 2019
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ArrestStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatric Clinical Research Platform
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, University of Lausanne Hospitals, Schutz & Rettung Sanitat, Salva Servizio Ambulanza Locarnese e Valli, Fribourg Emergency Medical Services, Fribourg, Switzerland, Réseau Hospitalier Neuchâtelois, Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland
- Responsible party
- Principal investigator, Johan Siebert, MD, University Hospital, Geneva
- Investigators
- Johan N Siebert, MD, Principal investigator, Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921346
- Sponsor's protocol ID
- SNSF_32003B_182374
- Status last verified
- Jun 2024
- First submitted
- 12 Apr 2019
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives at the Geneva Children's Hospital. The datasets used or analyzed during the current trial will be available from the corresponding author upon reasonable request. Only deidentified/anonymized data will be shared.
Publications
Siebert JN, Ehrler F, Combescure C, Lovis C, Haddad K, Hugon F, Luterbacher F, Lacroix L, Gervaix A, Manzano S; PedAMINES Trial Group. A mobile device application to reduce medication errors and time to drug delivery during simulated paediatric cardiopulmonary resuscitation: a multicentre, randomised, controlled, crossover trial. Lancet Child Adolesc Health. 2019 May;3(5):303-311. doi: 10.1016/S2352-4642(19)30003-3. Epub 2019 Feb 21.
PubMed 30797722Kaufmann J, Laschat M, Wappler F. Medication errors in pediatric emergencies: a systematic analysis. Dtsch Arztebl Int. 2012 Sep;109(38):609-16. doi: 10.3238/arztebl.2012.0609. Epub 2012 Sep 21.
PubMed 23093991Moreira ME, Hernandez C, Stevens AD, Jones S, Sande M, Blumen JR, Hopkins E, Bakes K, Haukoos JS. Color-Coded Prefilled Medication Syringes Decrease Time to Delivery and Dosing Error in Simulated Emergency Department Pediatric Resuscitations. Ann Emerg Med. 2015 Aug;66(2):97-106.e3. doi: 10.1016/j.annemergmed.2014.12.035. Epub 2015 Feb 18.
PubMed 25701295Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp MD, Federico F, Goldmann DA. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001 Apr 25;285(16):2114-20. doi: 10.1001/jama.285.16.2114.
PubMed 11311101Hoyle JD, Davis AT, Putman KK, Trytko JA, Fales WD. Medication dosing errors in pediatric patients treated by emergency medical services. Prehosp Emerg Care. 2012 Jan-Mar;16(1):59-66. doi: 10.3109/10903127.2011.614043. Epub 2011 Oct 14.
PubMed 21999707Hoyle JD Jr, Crowe RP, Bentley MA, Beltran G, Fales W. Pediatric Prehospital Medication Dosing Errors: A National Survey of Paramedics. Prehosp Emerg Care. 2017 Mar-Apr;21(2):185-191. doi: 10.1080/10903127.2016.1227001. Epub 2017 Feb 8.
PubMed 28257249Porter E, Barcega B, Kim TY. Analysis of medication errors in simulated pediatric resuscitation by residents. West J Emerg Med. 2014 Jul;15(4):486-90. doi: 10.5811/westjem.2014.2.17922.
PubMed 25035756Shah MN, Cushman JT, Davis CO, Bazarian JJ, Auinger P, Friedman B. The epidemiology of emergency medical services use by children: an analysis of the National Hospital Ambulatory Medical Care Survey. Prehosp Emerg Care. 2008 Jul-Sep;12(3):269-76. doi: 10.1080/10903120802100167.
PubMed 18584491Su E, Schmidt TA, Mann NC, Zechnich AD. A randomized controlled trial to assess decay in acquired knowledge among paramedics completing a pediatric resuscitation course. Acad Emerg Med. 2000 Jul;7(7):779-86. doi: 10.1111/j.1553-2712.2000.tb02270.x.
PubMed 10917328Matos RI, Watson RS, Nadkarni VM, Huang HH, Berg RA, Meaney PA, Carroll CL, Berens RJ, Praestgaard A, Weissfeld L, Spinella PC; American Heart Association's Get With The Guidelines-Resuscitation (Formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation. 2013 Jan 29;127(4):442-51. doi: 10.1161/CIRCULATIONAHA.112.125625. Epub 2013 Jan 22.
PubMed 23339874Andersen LW, Berg KM, Saindon BZ, Massaro JM, Raymond TT, Berg RA, Nadkarni VM, Donnino MW; American Heart Association Get With the Guidelines-Resuscitation Investigators. Time to Epinephrine and Survival After Pediatric In-Hospital Cardiac Arrest. JAMA. 2015 Aug 25;314(8):802-10. doi: 10.1001/jama.2015.9678.
PubMed 26305650Hansen M, Schmicker RH, Newgard CD, Grunau B, Scheuermeyer F, Cheskes S, Vithalani V, Alnaji F, Rea T, Idris AH, Herren H, Hutchison J, Austin M, Egan D, Daya M; Resuscitation Outcomes Consortium Investigators. Time to Epinephrine Administration and Survival From Nonshockable Out-of-Hospital Cardiac Arrest Among Children and Adults. Circulation. 2018 May 8;137(19):2032-2040. doi: 10.1161/CIRCULATIONAHA.117.033067. Epub 2018 Mar 6.
PubMed 29511001Fukuda T, Kondo Y, Hayashida K, Sekiguchi H, Kukita I. Time to epinephrine and survival after paediatric out-of-hospital cardiac arrest. Eur Heart J Cardiovasc Pharmacother. 2018 Jul 1;4(3):144-151. doi: 10.1093/ehjcvp/pvx023.
PubMed 29036580Foltin GL, Richmond N, Treiber M, Skomorowsky A, Galea S, Vlahov D, Blaney S, Kusick M, Silverman R, Tunik MG. Pediatric prehospital evaluation of NYC cardiac arrest survival (PHENYCS). Pediatr Emerg Care. 2012 Sep;28(9):864-8. doi: 10.1097/PEC.0b013e3182675e70.
PubMed 22929131Rittenberger JC, Bost JE, Menegazzi JJ. Time to give the first medication during resuscitation in out-of-hospital cardiac arrest. Resuscitation. 2006 Aug;70(2):201-6. doi: 10.1016/j.resuscitation.2005.12.006. Epub 2006 Jun 27.
PubMed 16806636
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Device App to Reduce Prehospital Medication Errors and Time to Drug Preparation and Delivery by EMS During Simulated Pediatric Cardiopulmonary Resuscitation: a Multicenter, Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03921346
- Acronym / sponsor ID
- SNSF_32003B_182374
- Conditions
- Cardiopulmonary Arrest, Resuscitation, Pediatrics, Medication Errors, Emergency Medical Services
- Keywords
- Medication errors, Drugs, Pediatrics, Biomedical Technology, Mobile applications, Emergency Medical Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Pediatric Clinical Research PlatformUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, University of Lausanne Hospitals, Schutz & Rettung Sanitat, Salva Servizio Ambulanza Locarnese e Valli, Fribourg Emergency Medical Services, Fribourg, Switzerland, Réseau Hospitalier Neuchâtelois, Morges & Aubonne Emergency Medical Services (CSUMA), Morges and Aubonne, Switzerland
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Posted 3 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigators will recruit paramedics in many Emergency Medical Services (EMS) in Switzerland to prepare direct intravenous (IV) emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario. According to randomization, each paramedic will be asked to prepare sequentially 4 IV emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of a mobile device app. This app is designed to support drug preparation at pediatric dosages. In a previous multicenter randomized trial with nurses, the investigators reported the ability of this app to significantly reduce in-hospital continuous infusion medication error rates and drug preparation time compared to conventional preparation methods during simulation-based resuscitations. In this trial, the aim was to assess this app during pediatric out-of-hospital cardiopulmonary resuscitation with paramedics.
Detailed description
Children represent a vulnerable population with specific medical needs compared to adults. Fast, accurate, and safe preparation and administration of IV drugs is both complex and time consuming in pediatric critical situations, such as cardiopulmonary resuscitation (CPR). Most drugs given IV to children are provided in vials originally prepared for the adult population, which leads to the need for a specific individual, weight-based drug dose calculation and preparation for each child that varies widely across age groups. This error-prone process and the lower dosing error tolerance of children place them at a high risk for life-threatening medication errors. Despite well equipped and staffed environments with numerous available safeguards, direct IV medication errors have been reported in up to 41% of cases during simulated in-hospital pediatric resuscitations, 65% of which were incorrect medication dosage, making it the most common error. The rate of errors is also important in the prehospital setting, occurring in more than 30% of all pediatric drugs administered. As paramedics have little exposure to critically ill children, they have limited opportunities to administer resuscitation drugs at pediatric doses and to train this skill.
Moreover, in resuscitation, time is inversely correlated to survival. During the first 15 min of in-hospital pediatric CPR, survival and favorable neurological outcome decrease linearly by 2,1% and 1,2% per min, respectively, and rely in part on drug preparation time either in- or out-of-hospital. Among non-shockable pediatric out-of-hospital cardiac arrests, each minute delay to epinephrine delivery is associated with 9% decrease in the odds of survival. Regrettably, in the prehospital setting, the majority of patients receive epinephrine more than 10 minutes after EMS arrival. The chain of survival therefore critically relies on early out-of-hospital CPR by EMS, and onsite administration of IV emergency drugs without delay before a rapid transfer to pediatric emergency departments and advanced care.
In a previous multicenter, randomized crossover trial, medication errors, time to drug preparation, and time to drug delivery for continuous infusions during simulation-based pediatric in-hospital postcardiac arrest scenarios were significantly reduced by using a mobile device app - the pediatric accurate medication in emergency situations (PedAMINES™) app - designed to help pediatric drug preparation.
The present multicenter trial aims to compare the impact of this app with conventional calculation methods for the preparation of direct IV drugs during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios. The investigators hypothesized that use of the app might extend and scale up the previous multicenter in-hospital observations by similarly reducing occurrence of medication errors and time to drug preparation and delivery when used by paramedics in out-of-hospital settings.
In this trial, the investigators will recruit paramedics in many EMS in Switzerland to prepare direct IV emergency drugs during a standardized simulation-based pediatric out-of-hospital cardiac arrest scenario with a high-fidelity WiFi manikin (Laerdal SimBaby). The scenario will take place out-of-hospital in a simulated children's room to increase realism.
On the day of participation after random allocation (1:1 allocation ratio), each participating paramedic will (1) complete a survey collecting data regarding their demographics, care training, and simulation and computer experience, (2) receive a standardized 5-min training session on how to use the app, and (3) be presented the simulation manikin characteristics. The paramedics will then be asked to perform a 20-min highly realistic pediatric CPR scenario on the high-fidelity manikin. Each paramedic will be asked to prepare sequentially 4 intravenous emergency drugs (epinephrine, midazolam, dextrose 10%, sodium bicarbonate 4.2%) following either their current conventional methods or by the aim of the mobile app. The procedure is standardized across all sites to follow the same chronological progression and range of difficulty to ensure each participant is exposed to exactly the same case, with similar challenges in decision making and treatment preparation provided on the same manikin.
All the actions (i.e. primary and secondary outcomes) performed by the paramedics during the scenario will be automatically recorded and stored by the responsive simulator detectors, the app, and by several GoPro Hero 5 Black edition action video cameras worn by the paramedics and placed within the room.
The study will be carried out in accordance with the Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH) guidelines and the Reporting Guidelines for Health Care Simulation Research.
This study aims to compare the impact of this app with conventional calculation methods for the preparation of direct IV drugs during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios, were paramedics are little exposed to pediatric CPRs. The investigators hypothesize that use of the app might extend and scale up their previous multicenter in-hospital observations by similarly reducing occurrence of medication errors and time to drug preparation and delivery when used by paramedics in out-of-hospital settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arm A (mobile device app) | Experimental | Device: Mobile device app (PedAMINES™) 1st drug, Device: Mobile device app (PedAMINES™) 2nd drug, Device: Mobile device app (PedAMINES™) 3rd drug, Device: Mobile device app (PedAMINES™) 4th drugParamedics preparing drugs with the help of the mobile device app PedAMINES™. Each paramedic will have to prepare sequentially 4 direct IV emergency drugs with the help of the mobile device app PedAMINES™. |
| Arm B (conventional preparation method) | Active comparator | Device: Conventional method 1st drug, Device: Conventional method 2nd drug, Device: Conventional method 3rd drug, Device: Conventional method 4th drugParamedics preparing drugs with the help of conventional method. Each paramedic will have to prepare sequentially 4 direct IV emergency drugs with the help of conventional method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To be paramedic certified
- To know how to prepare direct IV drugs
- To have previously completed the 5-minute introductory course to the use of the app PedAMINES™ dispensed by the study investigators
- Participation agreement
Key exclusion criteria (2 listed)
- To have at any time previously used the app PedAMINES™
- To have not undergone the 5-minute introductory course to the use of the app PedAMINES™
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 |
|---|---|---|
| Mobile device app (PedAMINES™) 1st drugTo prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration) | Device | Arm A (mobile device app) |
| Mobile device app (PedAMINES™) 2nd drugTo prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%) | Device | Arm A (mobile device app) |
| Mobile device app (PedAMINES™) 3rd drugTo prepare 4 mL/kg dextrose 10% | Device | Arm A (mobile device app) |
| Mobile device app (PedAMINES™) 4th drugTo prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration) | Device | Arm A (mobile device app) |
| Conventional method 1st drugTo prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration) | Device | Arm B (conventional preparation method) |
| Conventional method 2nd drugTo prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%) | Device | Arm B (conventional preparation method) |
| Conventional method 3rd drugTo prepare 4 mL/kg dextrose 10% | Device | Arm B (conventional preparation method) |
| Conventional method 4th drugTo prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration) | Device | Arm B (conventional preparation method) |
Primary outcome
Medication Dosage Errors
Time frame: 20 minutes
To measure in each allocation group the number and percentage of medication dosage containing errors that occur during the sequence from drug preparation to drug injection. We define an emergency medication dose administration error as a failure in drug preparation if at least one of the following errors is committed: a deviation in drug dose of more than 10% from the correct weight dose; inability to calculate drug dosage without guidance help from the paramedic investigator (LB) leading the resuscitation in the room; and/or (because of its clinical relevance) a deviation of more than 10% of the final administered concentration of sodium bicarbonate from the prescribed 4.2% concentration. These errors will be measured both as the percentage deviation from the amount of delivered drug compared with the correct weight dose as prescribed by the physician and the absolute deviations from that dose.
5 secondary outcomes
Time to Drug Preparation and Time to Drug Delivery
Time frame: 20 minutes
Type of Medication Errors
Time frame: During each of the 4 drug preparations, an average of 20 minutes per drug preparation.
Perceived Stress
Time frame: At preintervention and postintervention, a total of 20 minutes will be used to complete the STAI questionnaire.
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
Time frame: Baseline, recovery, and during each of the 4 drug preparations, a total of 20 minutes per participant will be used to continuously record heart rates on the smartwatch. Maximal HRpeak is the maximum HR across all preparations
Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30797722Siebert JN, Ehrler F, Combescure C, Lovis C, Haddad K, Hugon F, Luterbacher F, Lacroix L, Gervaix A, Manzano S; PedAMINES Trial Group. A mobile device application to reduce medication errors and time to drug delivery during simulated paediatric cardiopulmonary resuscitation: a multicentre, randomised, controlled, crossover trial. Lancet Child Adolesc Health. 2019 May;3(5):303-311. doi: 10.1016/S2352-4642(19)30003-3. Epub 2019 Feb 21.
- Background: PubMed 23093991Kaufmann J, Laschat M, Wappler F. Medication errors in pediatric emergencies: a systematic analysis. Dtsch Arztebl Int. 2012 Sep;109(38):609-16. doi: 10.3238/arztebl.2012.0609. Epub 2012 Sep 21.
- Background: PubMed 25701295Moreira ME, Hernandez C, Stevens AD, Jones S, Sande M, Blumen JR, Hopkins E, Bakes K, Haukoos JS. Color-Coded Prefilled Medication Syringes Decrease Time to Delivery and Dosing Error in Simulated Emergency Department Pediatric Resuscitations. Ann Emerg Med. 2015 Aug;66(2):97-106.e3. doi: 10.1016/j.annemergmed.2014.12.035. Epub 2015 Feb 18.
- Background: PubMed 11311101Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp MD, Federico F, Goldmann DA. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001 Apr 25;285(16):2114-20. doi: 10.1001/jama.285.16.2114.
- Background: PubMed 21999707Hoyle JD, Davis AT, Putman KK, Trytko JA, Fales WD. Medication dosing errors in pediatric patients treated by emergency medical services. Prehosp Emerg Care. 2012 Jan-Mar;16(1):59-66. doi: 10.3109/10903127.2011.614043. Epub 2011 Oct 14.
- Background: PubMed 28257249Hoyle JD Jr, Crowe RP, Bentley MA, Beltran G, Fales W. Pediatric Prehospital Medication Dosing Errors: A National Survey of Paramedics. Prehosp Emerg Care. 2017 Mar-Apr;21(2):185-191. doi: 10.1080/10903127.2016.1227001. Epub 2017 Feb 8.
- Background: PubMed 25035756Porter E, Barcega B, Kim TY. Analysis of medication errors in simulated pediatric resuscitation by residents. West J Emerg Med. 2014 Jul;15(4):486-90. doi: 10.5811/westjem.2014.2.17922.
- Background: PubMed 18584491Shah MN, Cushman JT, Davis CO, Bazarian JJ, Auinger P, Friedman B. The epidemiology of emergency medical services use by children: an analysis of the National Hospital Ambulatory Medical Care Survey. Prehosp Emerg Care. 2008 Jul-Sep;12(3):269-76. doi: 10.1080/10903120802100167.
- Background: PubMed 10917328Su E, Schmidt TA, Mann NC, Zechnich AD. A randomized controlled trial to assess decay in acquired knowledge among paramedics completing a pediatric resuscitation course. Acad Emerg Med. 2000 Jul;7(7):779-86. doi: 10.1111/j.1553-2712.2000.tb02270.x.
- Background: PubMed 23339874Matos RI, Watson RS, Nadkarni VM, Huang HH, Berg RA, Meaney PA, Carroll CL, Berens RJ, Praestgaard A, Weissfeld L, Spinella PC; American Heart Association's Get With The Guidelines-Resuscitation (Formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Duration of cardiopulmonary resuscitation and illness category impact survival and neurologic outcomes for in-hospital pediatric cardiac arrests. Circulation. 2013 Jan 29;127(4):442-51. doi: 10.1161/CIRCULATIONAHA.112.125625. Epub 2013 Jan 22.
- Background: PubMed 26305650Andersen LW, Berg KM, Saindon BZ, Massaro JM, Raymond TT, Berg RA, Nadkarni VM, Donnino MW; American Heart Association Get With the Guidelines-Resuscitation Investigators. Time to Epinephrine and Survival After Pediatric In-Hospital Cardiac Arrest. JAMA. 2015 Aug 25;314(8):802-10. doi: 10.1001/jama.2015.9678.
- Background: PubMed 29511001Hansen M, Schmicker RH, Newgard CD, Grunau B, Scheuermeyer F, Cheskes S, Vithalani V, Alnaji F, Rea T, Idris AH, Herren H, Hutchison J, Austin M, Egan D, Daya M; Resuscitation Outcomes Consortium Investigators. Time to Epinephrine Administration and Survival From Nonshockable Out-of-Hospital Cardiac Arrest Among Children and Adults. Circulation. 2018 May 8;137(19):2032-2040. doi: 10.1161/CIRCULATIONAHA.117.033067. Epub 2018 Mar 6.
- Individual participant dataSharing planned: Yes. IPD will be deidentified and the study investigators will house the data locally on secure hard disk drives at the Geneva Children's Hospital. The datasets used or analyzed during the current trial will be available from the corresponding author upon reasonable request. Only deidentified/anonymized data will be shared.
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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.
Johan N Siebert, MD principal investigator
Geneva Children's Hospital, Geneva University Hospitals, Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile device app (PedAMINES™) 1st drug, Mobile device app (PedAMINES™) 2nd drug and Mobile device app (PedAMINES™) 3rd drug in people with Cardiopulmonary Arrest and Resuscitation, run by Pediatric Clinical Research Platform at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 3 Oct 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Medication Dosage Errors (time frame: 20 minutes). 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 NCT03921346, which also lists 22 linked publications.
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 3 Oct 2024.