Trial Outcomes & Findings for Reducing Prehospital Medication Errors & Time to Drug Delivery by EMS During Simulated Pediatric CPR (NCT NCT03921346)
NCT ID: NCT03921346
Last Updated: 2024-10-03
Results Overview
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.
COMPLETED
NA
150 participants
20 minutes
2024-10-03
Participant Flow
Participant milestones
| Measure |
Arm A (Mobile Device App)
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™.
Mobile device app (PedAMINES™) 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Mobile device app (PedAMINES™) 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Mobile device app (PedAMINES™) 3rd drug: To prepare 4 mL/kg dextrose 10%
Mobile device app (PedAMINES™) 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
Arm B (Conventional Preparation Method)
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
Conventional method 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Conventional method 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Conventional method 3rd drug: To prepare 4 mL/kg dextrose 10%
Conventional method 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
76
|
|
Overall Study
COMPLETED
|
74
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A (Mobile Device App)
n=74 Participants
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™.
Mobile device app (PedAMINES™) 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Mobile device app (PedAMINES™) 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Mobile device app (PedAMINES™) 3rd drug: To prepare 4 mL/kg dextrose 10%
Mobile device app (PedAMINES™) 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
Arm B (Conventional Preparation Method)
n=76 Participants
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
Conventional method 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Conventional method 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Conventional method 3rd drug: To prepare 4 mL/kg dextrose 10%
Conventional method 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 7.3 • n=74 Participants
|
35.5 years
STANDARD_DEVIATION 7.1 • n=76 Participants
|
35.6 years
STANDARD_DEVIATION 7.2 • n=150 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=74 Participants
|
23 Participants
n=76 Participants
|
49 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=74 Participants
|
53 Participants
n=76 Participants
|
101 Participants
n=150 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Switzerland
|
74 participants
n=74 Participants
|
76 participants
n=76 Participants
|
150 participants
n=150 Participants
|
|
Proficiency in the use of smartphones or tablets (5-point Likert scale)
Strongly disagree
|
1 Participants
n=74 Participants
|
0 Participants
n=76 Participants
|
1 Participants
n=150 Participants
|
|
Proficiency in the use of smartphones or tablets (5-point Likert scale)
Disagree
|
3 Participants
n=74 Participants
|
3 Participants
n=76 Participants
|
6 Participants
n=150 Participants
|
|
Proficiency in the use of smartphones or tablets (5-point Likert scale)
Neutral
|
12 Participants
n=74 Participants
|
13 Participants
n=76 Participants
|
25 Participants
n=150 Participants
|
|
Proficiency in the use of smartphones or tablets (5-point Likert scale)
Agree
|
38 Participants
n=74 Participants
|
48 Participants
n=76 Participants
|
86 Participants
n=150 Participants
|
|
Proficiency in the use of smartphones or tablets (5-point Likert scale)
Strongly agree
|
20 Participants
n=74 Participants
|
12 Participants
n=76 Participants
|
32 Participants
n=150 Participants
|
|
Time since paramedic certification (years, categorical)
<5 years
|
26 Participants
n=74 Participants
|
27 Participants
n=76 Participants
|
53 Participants
n=150 Participants
|
|
Time since paramedic certification (years, categorical)
5 to10 years
|
29 Participants
n=74 Participants
|
26 Participants
n=76 Participants
|
55 Participants
n=150 Participants
|
|
Time since paramedic certification (years, categorical)
>10 years
|
19 Participants
n=74 Participants
|
23 Participants
n=76 Participants
|
42 Participants
n=150 Participants
|
|
Specific pediatric training (categorical)
Yes
|
37 Participants
n=74 Participants
|
35 Participants
n=76 Participants
|
72 Participants
n=150 Participants
|
|
Specific pediatric training (categorical)
No
|
37 Participants
n=74 Participants
|
41 Participants
n=76 Participants
|
78 Participants
n=150 Participants
|
|
Time since last pediatric cardiopulmonary resuscitation (months, categorical)
Never
|
32 Participants
n=74 Participants
|
30 Participants
n=76 Participants
|
62 Participants
n=150 Participants
|
|
Time since last pediatric cardiopulmonary resuscitation (months, categorical)
≥24
|
26 Participants
n=74 Participants
|
28 Participants
n=76 Participants
|
54 Participants
n=150 Participants
|
|
Time since last pediatric cardiopulmonary resuscitation (months, categorical)
12 to <24
|
11 Participants
n=74 Participants
|
11 Participants
n=76 Participants
|
22 Participants
n=150 Participants
|
|
Time since last pediatric cardiopulmonary resuscitation (months, categorical)
6 to <12
|
4 Participants
n=74 Participants
|
5 Participants
n=76 Participants
|
9 Participants
n=150 Participants
|
|
Time since last pediatric cardiopulmonary resuscitation (months, categorical)
<6
|
1 Participants
n=74 Participants
|
2 Participants
n=76 Participants
|
3 Participants
n=150 Participants
|
|
Time since last preparation of emergency drugs (months, categorical)
Never
|
9 Participants
n=74 Participants
|
12 Participants
n=76 Participants
|
21 Participants
n=150 Participants
|
|
Time since last preparation of emergency drugs (months, categorical)
≥24
|
18 Participants
n=74 Participants
|
18 Participants
n=76 Participants
|
36 Participants
n=150 Participants
|
|
Time since last preparation of emergency drugs (months, categorical)
12 to <24
|
15 Participants
n=74 Participants
|
17 Participants
n=76 Participants
|
32 Participants
n=150 Participants
|
|
Time since last preparation of emergency drugs (months, categorical)
6 to <12
|
17 Participants
n=74 Participants
|
7 Participants
n=76 Participants
|
24 Participants
n=150 Participants
|
|
Time since last preparation of emergency drugs (months, categorical)
<6
|
15 Participants
n=74 Participants
|
22 Participants
n=76 Participants
|
37 Participants
n=150 Participants
|
|
Satisfaction with current drug preparation methods (5-point Likert scale)
Very unsatisfied
|
9 Participants
n=74 Participants
|
8 Participants
n=76 Participants
|
17 Participants
n=150 Participants
|
|
Satisfaction with current drug preparation methods (5-point Likert scale)
Unsatisfied
|
18 Participants
n=74 Participants
|
19 Participants
n=76 Participants
|
37 Participants
n=150 Participants
|
|
Satisfaction with current drug preparation methods (5-point Likert scale)
Neutral
|
25 Participants
n=74 Participants
|
22 Participants
n=76 Participants
|
47 Participants
n=150 Participants
|
|
Satisfaction with current drug preparation methods (5-point Likert scale)
Satisfied
|
21 Participants
n=74 Participants
|
24 Participants
n=76 Participants
|
45 Participants
n=150 Participants
|
|
Satisfaction with current drug preparation methods (5-point Likert scale)
Very satisfied
|
1 Participants
n=74 Participants
|
3 Participants
n=76 Participants
|
4 Participants
n=150 Participants
|
|
Proficient with intravenous drug preparation (5-point Likert scale)
Strongly disagree
|
9 Participants
n=74 Participants
|
7 Participants
n=76 Participants
|
16 Participants
n=150 Participants
|
|
Proficient with intravenous drug preparation (5-point Likert scale)
Disagree
|
15 Participants
n=74 Participants
|
30 Participants
n=76 Participants
|
45 Participants
n=150 Participants
|
|
Proficient with intravenous drug preparation (5-point Likert scale)
Neutral
|
30 Participants
n=74 Participants
|
14 Participants
n=76 Participants
|
44 Participants
n=150 Participants
|
|
Proficient with intravenous drug preparation (5-point Likert scale)
Agree
|
19 Participants
n=74 Participants
|
22 Participants
n=76 Participants
|
41 Participants
n=150 Participants
|
|
Proficient with intravenous drug preparation (5-point Likert scale)
Strongly agree
|
1 Participants
n=74 Participants
|
3 Participants
n=76 Participants
|
4 Participants
n=150 Participants
|
|
Attitude toward new technology (5-point Likert scale)
Strongly unfavorable
|
0 Participants
n=74 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=150 Participants
|
|
Attitude toward new technology (5-point Likert scale)
Unfavorable
|
0 Participants
n=74 Participants
|
1 Participants
n=76 Participants
|
1 Participants
n=150 Participants
|
|
Attitude toward new technology (5-point Likert scale)
Neutral
|
6 Participants
n=74 Participants
|
1 Participants
n=76 Participants
|
7 Participants
n=150 Participants
|
|
Attitude toward new technology (5-point Likert scale)
Favorable
|
24 Participants
n=74 Participants
|
17 Participants
n=76 Participants
|
41 Participants
n=150 Participants
|
|
Attitude toward new technology (5-point Likert scale)
Strongly favorable
|
44 Participants
n=74 Participants
|
57 Participants
n=76 Participants
|
101 Participants
n=150 Participants
|
PRIMARY outcome
Timeframe: 20 minutesTo 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.
Outcome measures
| Measure |
Arm A (Mobile Device App)
n=74 Participants
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™.
Mobile device app (PedAMINES™) 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Mobile device app (PedAMINES™) 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Mobile device app (PedAMINES™) 3rd drug: To prepare 4 mL/kg dextrose 10%
Mobile device app (PedAMINES™) 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
Arm B (Conventional Preparation Method)
n=76 Participants
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
Conventional method 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Conventional method 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Conventional method 3rd drug: To prepare 4 mL/kg dextrose 10%
Conventional method 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
|---|---|---|
|
Medication Dosage Errors
|
5.7 percentage of medication errors
Interval 3.4 to 9.0
|
62.8 percentage of medication errors
Interval 57.1 to 68.3
|
SECONDARY outcome
Timeframe: 20 minutesSecondary 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.
Outcome measures
| Measure |
Arm A (Mobile Device App)
n=74 Participants
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™.
Mobile device app (PedAMINES™) 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Mobile device app (PedAMINES™) 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Mobile device app (PedAMINES™) 3rd drug: To prepare 4 mL/kg dextrose 10%
Mobile device app (PedAMINES™) 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
Arm B (Conventional Preparation Method)
n=76 Participants
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
Conventional method 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Conventional method 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Conventional method 3rd drug: To prepare 4 mL/kg dextrose 10%
Conventional method 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
|---|---|---|
|
Time to Drug Preparation and Time to Drug Delivery
Time to drug preparation
|
146.6 seconds
Interval 95.3 to 198.0
|
186.1 seconds
Interval 134.8 to 237.4
|
|
Time to Drug Preparation and Time to Drug Delivery
Time to drug delivery
|
186.8 seconds
Interval 142.1 to 231.4
|
233.3 seconds
Interval 188.7 to 277.9
|
SECONDARY outcome
Timeframe: During each of the 4 drug preparations, an average of 20 minutes per drug preparation.Population: Categories are not mutually exclusive. Various errors can occur during each drug preparation and therefore can be counted more than once
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.
Outcome measures
| Measure |
Arm A (Mobile Device App)
n=296 Drug preparations
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™.
Mobile device app (PedAMINES™) 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Mobile device app (PedAMINES™) 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Mobile device app (PedAMINES™) 3rd drug: To prepare 4 mL/kg dextrose 10%
Mobile device app (PedAMINES™) 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
Arm B (Conventional Preparation Method)
n=304 Drug preparations
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
Conventional method 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Conventional method 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Conventional method 3rd drug: To prepare 4 mL/kg dextrose 10%
Conventional method 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
|---|---|---|
|
Type of Medication Errors
Dose deviation >10%
|
16 Drug preparations
|
172 Drug preparations
|
|
Type of Medication Errors
Help required
|
0 Drug preparations
|
55 Drug preparations
|
|
Type of Medication Errors
Incorrect preparations
|
17 Drug preparations
|
191 Drug preparations
|
|
Type of Medication Errors
4th drug concentration deviation >10%
|
5 Drug preparations
|
46 Drug preparations
|
SECONDARY outcome
Timeframe: At preintervention and postintervention, a total of 20 minutes will be used to complete the STAI questionnaire.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.
Outcome measures
| Measure |
Arm A (Mobile Device App)
n=73 Participants
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™.
Mobile device app (PedAMINES™) 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Mobile device app (PedAMINES™) 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Mobile device app (PedAMINES™) 3rd drug: To prepare 4 mL/kg dextrose 10%
Mobile device app (PedAMINES™) 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
Arm B (Conventional Preparation Method)
n=76 Participants
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
Conventional method 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Conventional method 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Conventional method 3rd drug: To prepare 4 mL/kg dextrose 10%
Conventional method 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
|---|---|---|
|
Perceived Stress
STAI preintervention
|
36.1 score on a scale
Standard Deviation 8.1
|
35.4 score on a scale
Standard Deviation 8.2
|
|
Perceived Stress
STAI postintervention
|
39.0 score on a scale
Standard Deviation 8.4
|
49.8 score on a scale
Standard Deviation 13.2
|
|
Perceived Stress
VAS preintervention
|
4.2 score on a scale
Standard Deviation 2.5
|
3.9 score on a scale
Standard Deviation 2.2
|
|
Perceived Stress
VAS postintervention
|
6.4 score on a scale
Standard Deviation 1.9
|
7.1 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 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 preparationsPopulation: Outcome measures are expressed as mean \[SD\] beats per minute per study group (with no minimum nor maximum values as heart rates can vary greatly between individuals)
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.
Outcome measures
| Measure |
Arm A (Mobile Device App)
n=73 Participants
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™.
Mobile device app (PedAMINES™) 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Mobile device app (PedAMINES™) 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Mobile device app (PedAMINES™) 3rd drug: To prepare 4 mL/kg dextrose 10%
Mobile device app (PedAMINES™) 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
Arm B (Conventional Preparation Method)
n=76 Participants
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
Conventional method 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Conventional method 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Conventional method 3rd drug: To prepare 4 mL/kg dextrose 10%
Conventional method 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
|---|---|---|
|
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
Maximal HRpeak
|
126.1 Beats per minute
Standard Deviation 10.3
|
126.0 Beats per minute
Standard Deviation 12.1
|
|
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
Recovery (directly after the intervention, at rest in the absence of drug preparation)
|
79.3 Beats per minute
Standard Deviation 15.0
|
76.8 Beats per minute
Standard Deviation 13.7
|
|
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
Baseline heart rate (HR)
|
79.3 Beats per minute
Standard Deviation 14.4
|
78.5 Beats per minute
Standard Deviation 12.7
|
|
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
First drug, HRpeak
|
123.1 Beats per minute
Standard Deviation 9.2
|
124.1 Beats per minute
Standard Deviation 12.2
|
|
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
Second drug, HRpeak
|
121.1 Beats per minute
Standard Deviation 10.9
|
119.9 Beats per minute
Standard Deviation 13.3
|
|
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
Third drug, HRpeak
|
120.4 Beats per minute
Standard Deviation 11.4
|
117.9 Beats per minute
Standard Deviation 13.3
|
|
Stress Level Measured by Heart Rate Monitoring (Smartwatch).
Fourth drug, HRpeak
|
114.1 Beats per minute
Standard Deviation 13.5
|
110.5 Beats per minute
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: 60 minutesUnified 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)
Outcome measures
| Measure |
Arm A (Mobile Device App)
n=74 Participants
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™.
Mobile device app (PedAMINES™) 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Mobile device app (PedAMINES™) 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Mobile device app (PedAMINES™) 3rd drug: To prepare 4 mL/kg dextrose 10%
Mobile device app (PedAMINES™) 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
|
Arm B (Conventional Preparation Method)
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
Conventional method 1st drug: To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
Conventional method 2nd drug: To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
Conventional method 3rd drug: To prepare 4 mL/kg dextrose 10%
Conventional method 4th drug: To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
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Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Performance expectancy - UTAUT
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4.55 score on a scale
Standard Deviation 0.59
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Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Behavioral intention to use the technology - UTAUT
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4.81 score on a scale
Standard Deviation 0.34
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Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Perceived usefulness - UTAUT
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4.69 score on a scale
Standard Deviation 0.44
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Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Perceived ease of use - UTAUT
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4.61 score on a scale
Standard Deviation 0.35
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Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Task-technology fit - UTAUT
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4.49 score on a scale
Standard Deviation 0.54
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Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Impact on image - UTAUT
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4.74 score on a scale
Standard Deviation 0.57
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Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Personal innovativeness - UTAUT
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4.14 score on a scale
Standard Deviation 0.58
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Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
Acceptance - UTAUT
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4.32 score on a scale
Standard Deviation 0.61
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Unified Theory of Acceptance and Use of Technology (UTAUT) Questionnaire and System Usability Score (SUS)
SUS
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89.7 score on a scale
Standard Deviation 8.7
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Adverse Events
Arm A (Mobile Device App)
Arm B (Conventional Preparation Method)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place