Adverse events during mechanical ventilation are ubiquitous in hospitals. In a retrospective analysis, 5.6% of patients were affected with a ventilator-associated condition (28).The CDC has defined objective criteria for ventilator-associated events (VAE)(29, 30) These are a "deterioration in respiratory status, infection or inflammation, and laboratory evidence of respiratory infection" with guidance for a treatment pathway/algorithm to detect these adverse events. These data and outcomes do not exist for care in the home setting. Medical criteria for the detection of pneumonia and infection apply, of course, yet the home setting is characterised by a single responsible caregiver. Therefore, our method-mix in data collection focused on a subjective assessment of risks in respiratory care. Based on these results, we integrated these data with existing guideline literature and systematic error analysis methods. The result is an error-cause diagram and a list of recommendations for action. The recommendations for action address the protagonists of the entire socio-technical system. The nursing staff as well as training, manufacturers and the organisation are responsible when it comes to improving patient safety in home ventilation. Only multicausal prevention concepts can lead to the avoidance of adverse events. This cause-and-effect diagram and the recommendations for action can be used by manufacturers to improve their equipment and expand education concepts for organisations and nursing schools to include the risks mentioned here.
The number of causes shows how widespread potential patient harm is. The questionnaire was more dedicated to the level of harm than the likelihood of occurrence in home ventilation. Here, activities such as ventilation settings, cannula change and transport of the patient were seen as the cause of most AE. De-cannulation of the ventilation tube and oral care, suction were rated as the most dangerous cause of adverse outcomes. Nurses wanted support in patient transfer, mobilisation and positioning of the patient, as well as checklists for nursing actions and reminder functions for activities on the ventilator (tube change). In the literature, however, AE are more associated with medication errors, decubitus and misdiagnosis. In general, the evidence on AE in the home setting is poor (8, 31, 5). It is estimated that 10% of hospital admissions are due to a patient harm that could have been avoided (32). Approximately four in 10 patients experience harm in the outpatient setting (5). In(33) it was shown that out of 189 reported events, 39% were due to device error, all other errors were due to caregiver causes (e.g. improper device use). Risk mitigation measures are required by regulation for medical device manufacturers(18) but not for care providers. Nevertheless, also care providers should be able to identify foreseeable risks and take actions and measures to prevent AE (34).
Adverse events do not fall out of the blue. They are subject to a certain statistical distribution and are thus omnipresent! It is only a matter of time when and whom adverse events hit. A transparency for the occurrence of adverse events gives the nursing staff the competence to react early to possible causes or to be able to act in emergency situations. Therefore, an analysis of the home environment in which a seriously ill person is cared for is essential. Risk management measures must be taken for the care processes and possible causes so that adverse events cannot cause harm.
Limitations
The limitations are the small number of test persons and the small number of different home care providers and ICU. Only employees of the project partners took part, which might have resulted in response bias. In a further study it would be desirable to interview additional Home ventilation services in order to get a more diverse picture of approaches to dealing with adverse events. In question no. 3 the terms cannula change, device maintenance, goose gargle change, ventilation filter change, inhalation and adjustment of ventilation parameters were not asked. Since these terms are missing, a distorted result is to be expected for the lower ranks. One problem was that the recommendations for action would have had to be validated by the probands in a further step in order to identify queries and further causes. A further analysis loop with the involvement of the proband would have been useful and represents the focus of future research.
Conclusion
In this study, the need for action to prevent the occurrence of adverse events from the point of view of the nursing staff was determined. For this purpose, risks in home ventilation were identified based on expert interviews and questionnaires. In an analysis process, the collected data were systematically mapped onto a root-cause diagram. The grouping of adverse events, risks and hazards led to a categorisation that enables a targeted reduction of hazards. For manufacturers, but also for caregivers and care services, the work offers the possibility to expand the list of hazards, to create a checklist for particularly risky care actions and to develop ideas for innovative decision-making and equipment support.