The Emergency Paramedic Act (Notfallsanitätergesetz; NotSanG) law, introduced in 2014, restructured the education of German ambulance personnel. The title of paramedic (Notfallsanitär) superseded rescue assistant (Rettungsassistent), which had been introduced in 1989. A transition period to allow time for rescue assistant to upskill to become paramedics and for student paramedics to gain their qualifications is under way.
During the transition period, the two roles are being treated equally as having the mandatory qualification for being a paramedic in charge on an ambulance (Federal Office of Justice, 2014). However, paramedic training has been completely restructured.
The NotSanG was introduced at federal level, so created a framework in which the ambulance service areas of the 16 federal states in Germany can draw up individual guidelines. The local medical director in each ambulance service determines standard operating procedures (SOPs) and medication the ambulance personnel in that area can use (Federal Office of Justice, 2014; Lechleuthner and Neupert, 2015).
The NotSanG regulates the 3-year professional training, including the scope of clinical skills (Federal Office of Justice, 2014). While the rescue assistant, who trained for 2 years, is supposed to use invasive procedures only for life-saving purposes (Bundesgesetztblatt, 1989), the paramedic can ‘independently apply standard medical procedures that are authorised by the local medical director of the ambulance service for certain emergency medical conditions and situations’ (Federal Office of Justice, 2014).
One such therapeutic procedure is analgesia for severe pain. Most of these procedures require peripheral intravenous (IV) access. Therefore, gaining vascular access is a fundamental and essential practice in the daily work of the ambulance service. It will be required for example if a medication is only available as an IV option or if the patient is not conscious so cannot take oral medication.
During training, the student paramedic has 1600 hours placement on ambulances and 720 hours in different hospital departments to learn and develop cannulation skills (Federal Office of Justice, 2013).
Over their 3 years of training, student paramedics acquire more competencies so they can legally carry out duties that were formerly done by prehospital emergency physicians (PHEP).
The council of medical directors in the German state of Hesse, where this study took place, recommends SOPs to Hesse's local medical directors. These SOPs include 26 substances that can be administered by paramedics. Twelve of these are administered intravenously. The SOPs on IV drug administration include analgesia SOPs, which are probably the most frequently used SOPs (Hessian Ministry for Social Affairs and Integration, 2018). An alternative route is allowed for only two of the 12 substances: midazolam can be administered nasally and epinephrine intraosseously (during cardiopulmonary resuscitation) as a second-line option.
Establishing IV access is therefore a critical technique for paramedics if they are to apply these SOPs to treat their patients successfully. However, it is well known that establishing vascular access or administrating IV drugs is vulnerable to errors (Taxis and Barber, 2004; Hoefel et al, 2008; Prottengeier et al, 2017; Wondmieneh et al, 2020).
Prottengeier et al (2017) examined the reasons for cannulation failure and compared the reasons why Bavarian paramedics and PHEPs failed to cannulate. However, the SOPs in Bavaria are more strongly focused on PHEP back-up calls than those in other German federal states so it is difficult to transfer these findings and understand their consequences in other settings.
To the best of the authors' knowledge, there is little or no evidence about the success rates of German paramedics in gaining vascular access. Therefore, this study aimed to assess the skills of paramedics in the federal state of Hesse focusing on the success rates in establishing vascular access.
Method
Study design
This was a single-centre, observational survey study in the state of Hesse, with the research period running from 25 May 2020 to 5 July 2020. Paramedics working for the Arbeiter Samariter Bund (Workers' Samaritan Federation; ASB) in the city of Darmstadt were asked to report on vascular access procedures they had to perform in adult patients.
The ambulance hub covers the urban area of southern Darmstadt as well as the rural and suburban areas in the district of Darmstadt-Dieburg. A standardised online survey tool, created using Google Forms, was to be completed after every vascular access attempt in addition to the regular medical report. This survey questions included:
The study protocol was reviewed, and the conduction of the study approved by ASB Darmstadt.
Statistical analysis
The characteristics of the IV attempts were described through means and corresponding standard deviations (SD) or frequencies.
To identify variables associated with a greater risk of IV failure, univariate analysis using the χ2 test, Fisher's exact test or logistic regression model was applied.
For all the analyses, the odds ratios (OR) and corresponding 95% confidence intervals (95% CI) were calculated and a p-value of 0.05 was considered statistically significant. Statistical analysis was performed using JASP software.
Results
Vascular access attempt characteristics
A total of 207 vascular access attempts by paramedics were included in the final analysis (Table 1). The mean age of patients was 65.36 (SD 23.81) years, and the majority of paramedics had been working in the emergency service for 10 years or longer (70.53% versus 29.47% who had worked for 1–5 years). There were no paramedics participating with 6-9 years of experience.
| Characteristics | Vascular access attempts (n=207) |
|---|---|
| Mean age of patients in years (SD) | 65.36 (23.81) |
| Mean years in emergency service | 1–5 years: 29.47% |
| Mean number of attempts to provide access (SD) | 1.30 (0.59) |
Paramedics made a mean number of 1.30 (SD 0.59) attempts to gain vascular access. In total, 90.34% of vascular access attempts were successful (Table 2); of these, 75.36% were made in one attempt, 10.63% required two and 4.35% needed three or more.
| Number of attempts | Success rate |
|---|---|
| 1 | 75.36% |
| 2 | 10.63% |
| ≥3 | 4.35% |
| Total | 90.34% |
When only one attempt was conducted, the success rate was 98.73% (n=158), compared to 59.46% (n=37) for two attempts and 75.00% (n=12) for three or more attempts.
Variables associated with failure to establish vascular access
Statistical analysis indicated that increasing age of patients was associated with a higher risk of failing to gain vascular access (OR 1.05; 95% CI (1.02–1.10); p=0.041). In addition, when two (OR 3.94; 95% CI (2.39–6.20); p≤0.001) or three or more attempts (OR 3.26; 95% CI (1.35; 5.17); p=0.003) were made, the risk of failure was significantly higher than when only one attempt was made (Table 3).
| Variable | Subgroups | Failure rate | Odds ratio (95% CI); p-value |
|---|---|---|---|
| Patient age | Increasing age (n=207) | 1.12 (1.06; 1.18); p≤0.001* | |
| Maximum number of attempts | 1 attempt (n=158) |
1.27% |
Reference |
| Years in emergency service | 1–5 years (n=61) |
6.56% |
Reference |
| Time of shift | Day shift (n=152) |
13.16% |
Reference |
| Blood pressure | Normal (n=121) |
14.05% |
Reference |
| Critical condition | No (n=84) |
5.95% |
Reference |
| Vein status: visibility/palpatability | Bad (n=44) |
38.64% |
Reference |
During night shifts (OR 0.06; 95% CI (0.00–0.98); p=0.005) the risk of IV failure was significantly lower than during day shifts.
In patients with a good (OR 0.02; 95% CI (0.00–0.15); p≤0.001) or moderate (OR 0.04; 95% CI (0.01–0.17); p≤0.001) vein status, gaining access was significantly more likely than in patients with a bad vein status.
Blood pressure, being in a critical condition and length of employment in emergency services were not significantly associated with being less likely to fail to gain vascular access in this study.
Discussion
The results of this pilot study indicate that 90% of vascular access attempts by paramedics were successful and that the likelihood of failure was associated with greater patient age, a higher number of attempts needed to provide access, poorer vein status and being on a daytime shift.
In this study, the percentage of successful first attempts was around 10 percentage points (75.36% versus 85%) lower than that in the analysis of Prottengeier et al (2017), while successful second (10.63% versus 11%) and third (4.35% versus 4%) attempts at gaining vascular access were comparable.
The number of attempts to establish vascular access was significantly associated with a higher risk of failure—multiple attempts had failure rates up to four times higher than single attempts. It is therefore key to train paramedics to improve there skills to provide fast, accurate access at the first attempt.
It important to mention that 9.66% of all attempts to gain vascular access in this study finally failed. Only two of the 12 drugs that are supposed to be given intravenously have an alternative administration route as a second-line option (Hessian Ministry for Social Affairs and Integration, 2018). This means that a significant number of patients did not receive the treatment they needed or a PHEP was sent to the scene to establish access or administer the medication required through another route.
It is well known that IV medication administration has a high incidence of errors (Westbrook et al, 2011; Ong and Subasyini, 2013). A study involving nurses showed that almost 70% of all IV administrations involved at least one clinical error (Westbrook et al, 2011). Westbrook et al (2011) also found that the risk and severity of errors decreased with the clinical experience of the nurses.
The present study did not identify a significant relationship between failure to gain access and years of work experience. The difference in failure rates of more experienced paramedics was non-significant.
One explanation could be that not all IV cannulae are placed to for an intervention. Some are for services for accident and emergency hospital staff, for example when paramedics take blood samples. It could be that less experienced paramedics do not even try to cannulate if this is only to collect a blood sample for a hospital when they are struggling to find a vein. Another explanation is that more experienced paramedics are more frequently accompanied by student paramedics, and delegate cannulation to them.
Student paramedics rarely work night shifts, which could help to explain why the success rate is 100% during night shifts and significantly lower during day shifts. However, previous studies on medication errors have shown that error rates are significantly lower during day shifts than night shifts (Miller at al, 2010; Wondmieneh et al, 2020). Therefore, more studies on the effect of the working during the day or at night on paramedics' success in gaining IV access are needed.
Factors also associated with success and failure of gaining vascular access were patient age and vein status. These findings are comparable to previous results that indicate a higher risk of failure with increasing age (Prottengeier et al, 2017). Nevertheless, other studies have reported that patient age does not affect cannulation success rates (Coventry et al, 2019).
Bad vein status, based on visibility and palpability, was associated with a significantly higher failure rate in this study. These results are in line with previous non-paramedic studies. Jacobson et al (2005) reported that IV cannula insertion failures were associated with higher degrees of vein-related difficulties such as not visible, not palpable or rolled veins. A second study found a correlation between great vein diameter and a shorter time period to gain IV access (Kaiser et al, 2020).
This survey invites an examination of how German paramedics are trained in the technique of placing IV cannulas. This survey shows there is a need for SOPs so paramedics will have second-line options for analgesia if an IV cannula cannot be placed.
Limitations
This study has several limitations.
First, the number of vascular access attempts included was small. Numbers became even smaller in subgroups for statistical analysis, which resulted in wide 95% confidence intervals. This is because the data collection was part of a student assignment, which limited the data collection period.
Second, as all observational studies rely on volunteer participation, there might be selection bias. Unfortunately, the authors cannot say how frequently treatment was delayed or not provided because cannulation attempts were unsuccessful.
Third, the study was conducted during the SARS-CoV-2 pandemic and the authors cannot estimate how the pandemic affected the outcome of this study.
Fourth, this is a single-centre study so the results may not be representative of Germany.
This was a pilot study and, given its results, further studies with more variables should be carried out to identify further risk factors associated with vascular vein status and failure to gain IV access.
Conclusion
Although this small, exploratory pilot study is limited by the small number of vascular attempts included, some conclusions are possible.
First and unsurprisingly, not all IV cannulas were placed successfully. If paramedics are expected to carry out invasive procedures independently, there have to be alternative administration routes in case of IV access failure.
Furthermore, research is needed to investigate how German paramedics learn and maintain the skills of cannulating veins. There may be room for improvement to increase the success rate of establishing IV access in out-of-hospital settings.