An interventional study of Mobile device app (PedAMINES™) 1st drug and Mobile device app (PedAMINES™) 2nd drug in Cardiopulmonary Arrest, Resuscitation and Pediatrics, sponsored by Pediatric Clinical Research Platform. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Pediatric Clinical Research Platform · Not applicable, Interventional, and Treatment
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.
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Pediatric Clinical Research Platform is the lead sponsor of 13 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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™.
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
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
Device: Conventional method 1st drug · Device: Conventional method 2nd drug · Device: Conventional method 3rd drug · Device: Conventional method 4th drug
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
To prepare 4 mL/kg dextrose 10%
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
To prepare 4 mL/kg dextrose 10%
To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
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.
Time frame: 20 minutes
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.
Time frame: 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.
Time frame: 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.
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).
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.
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)
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)
Time frame: 60 minutes
| Milestone | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) |
|---|---|---|
| Started | 74 | 76 |
| Completed | 74 | 76 |
| Not completed | 0 | 0 |
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.
| percentage of medication errors | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) |
|---|---|---|
| Medication Dosage Errors | 5.7 (3.4 to 9.0) | 62.8 (57.1 to 68.3) |
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.
| seconds | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) |
|---|---|---|
| Time to drug preparation | 146.6 (95.3 to 198.0) | 186.1 (134.8 to 237.4) |
| Time to drug delivery | 186.8 (142.1 to 231.4) | 233.3 (188.7 to 277.9) |
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.
| Drug preparations | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) |
|---|---|---|
| Incorrect preparations | 17 | 191 |
| Dose deviation >10% | 16 | 172 |
| Help required | 0 | 55 |
| 4th drug concentration deviation >10% | 5 | 46 |
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.
| score on a scale | Mobile App | Conventional Method |
|---|---|---|
| STAI preintervention | 36.1 ± 8.1 | 35.4 ± 8.2 |
| STAI postintervention | 39.0 ± 8.4 | 49.8 ± 13.2 |
| VAS preintervention | 4.2 ± 2.5 | 3.9 ± 2.2 |
| VAS postintervention | 6.4 ± 1.9 | 7.1 ± 1.8 |
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.
| Beats per minute | Mobile App | Conventional Method |
|---|---|---|
| Baseline heart rate (HR) | 79.3 ± 14.4 | 78.5 ± 12.7 |
| First drug, HRpeak | 123.1 ± 9.2 | 124.1 ± 12.2 |
| Second drug, HRpeak | 121.1 ± 10.9 | 119.9 ± 13.3 |
| Third drug, HRpeak | 120.4 ± 11.4 | 117.9 ± 13.3 |
| Fourth drug, HRpeak | 114.1 ± 13.5 | 110.5 ± 13.7 |
| Recovery (directly after the intervention, at rest in the absence of drug preparation) | 79.3 ± 15.0 | 76.8 ± 13.7 |
| Maximal HRpeak | 126.1 ± 10.3 | 126.0 ± 12.1 |
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)
| score on a scale | Arm A (Mobile Device App) |
|---|---|
| Perceived usefulness - UTAUT | 4.69 ± 0.44 |
| Perceived ease of use - UTAUT | 4.61 ± 0.35 |
| Task-technology fit - UTAUT | 4.49 ± 0.54 |
| Performance expectancy - UTAUT | 4.55 ± 0.59 |
| Impact on image - UTAUT | 4.74 ± 0.57 |
| Personal innovativeness - UTAUT | 4.14 ± 0.58 |
| Acceptance - UTAUT | 4.32 ± 0.61 |
| Behavioral intention to use the technology - UTAUT | 4.81 ± 0.34 |
| SUS | 89.7 ± 8.7 |
Collected over 0. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A (Mobile Device App) | — | — | — |
| Arm B (Conventional Preparation Method) | — | — | — |
| Age, Continuous(years) | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) | Total |
|---|---|---|---|
| Mean | 35.7 ± 7.3 | 35.5 ± 7.1 | 35.6 ± 7.2 |
| Sex: Female, Male(Participants) | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) | Total |
|---|---|---|---|
| Female | 26 | 23 | 49 |
| Male | 48 | 53 | 101 |
| Race and Ethnicity Not Collected(Participants) | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) | Total |
|---|---|---|---|
| Switzerland | 74 | 76 | 150 |
| Proficiency in the use of smartphones or tablets (5-point Likert scale)(Participants) | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) | Total |
|---|---|---|---|
| Strongly disagree | 1 | 0 | 1 |
| Disagree | 3 | 3 | 6 |
| Neutral | 12 | 13 | 25 |
| Agree | 38 | 48 | 86 |
| Strongly agree | 20 | 12 | 32 |
| Time since paramedic certification (years, categorical)(Participants) | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) | Total |
|---|---|---|---|
| <5 years | 26 | 27 | 53 |
| 5 to10 years | 29 | 26 | 55 |
| >10 years | 19 | 23 | 42 |
| Specific pediatric training (categorical)(Participants) | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) | Total |
|---|---|---|---|
| Yes | 37 | 35 | 72 |
| No | 37 | 41 | 78 |
| Time since last pediatric cardiopulmonary resuscitation (months, categorical)(Participants) | Arm A (Mobile Device App) | Arm B (Conventional Preparation Method) | Total |
|---|---|---|---|
| Never | 32 | 30 | 62 |
| ≥24 | 26 | 28 | 54 |
| 12 to <24 | 11 | 11 | 22 |
| 6 to <12 | 4 | 5 | 9 |
| <6 | 1 | 2 | 3 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol
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