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| Name | Class |
|---|---|
| Hopital Neuchatelois | OTHER |
| Domo-Safety S.A. | UNKNOWN |
| Vivactis (Suisse) S.A. | UNKNOWN |
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Aging of the population is dramatically increasing the number of hospitalized patients, with the consequent challenges of limited medical personnel and resources in hospitals. Wireless technologies that create highly connected healthcare environments are developed to help hospitals address these issues, once these technologies are perfectly integrated in the hospital environment with respect to IT infrastructure for big data storage. Such devices have proven remarkable efficiencies in monitoring patients with high patient safety, data accuracy and security, which are essential to provide high quality patient care, reduce health-related costs and optimize the management of high numbers of patients.
Cough is the most common condition that results in a visit to the physician. Often coughs are benign, but sometimes can be the sign of exacerbations of a chronic respiratory disease. Exacerbations are defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) document "as an acute event characterised by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication". It is assumed that, if coughs were remotely monitored, hospitals might be unburdened, patients would be empowered to self-manage their health, and that prevention of serious respiratory diseases might be facilitated, thus improving health outcomes. Unfortunately, remote monitoring for cough that rely on self-reporting is impractical, as patients do not record data very reliably. On the contrary, a bed sensor under the mattress connected to a medical data analysis platform might monitor patients' micro-movements at night and alert the medical staff as soon as there is a cough exacerbation.
The clinical study is designed as a prospective observational pilot study to evaluate the reliability of a wireless bed sensor and data analysis platform to monitor coughs in hospitalized patients with respiratory diseases.
The study includes three phases:
3 Data analysis phase: to correlate bed sensor's signals with the AV recorded data. AV data as well computing will enable to determine the sensitivity and the selectivity of the device-generated signals.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wireless bed sensor | Device | Remote data collection |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the clinical performance and accuracy of the bed sensor and of the analysis platform to detect coughs | Comparison of the % of coughs detected by the connected device and the % of coughs detected by the AV system coupled to the polygraph recordings. Comparison of control and experimental groups will be performed using t-test for continuous variable. Difference with probability values > 0.05 will be considered insignificant. | 2 nights |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' acceptance on the connected device | Determination of the level of acceptance of the device by patients by means of a patient questionnaire to provide feedback. Usability for patients will be assessed by the % rate of acceptance for the patients. | 2 nights |
| Medical staff's satisfaction on both the device and the medical analysis platform (usability, data usage) |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female subjects aged ≥ 18 years fulfilling all of the inclusion criteria are eligible for the study. The presence of any one of the exclusion criteria will lead to exclusion of the participant.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012120 | Respiration Disorders |
| D003371 | Cough |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Assessment of the satisfaction of the medical staff regarding the usability of the device and of the device-generated data by means of a health professional questionnaire to provide feedback. Usability for healthcare professionals will be assessed by the % rate of satisfaction for the healthcare professionals. |
| 5 days |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |