The EarlySense system, using the Vitals software option, is used to continuously monitor heart rate and respiratory rate for patients in hospital. A sensor placed under the mattress continuously collects data while the patient is in bed and the system alerts healthcare professionals if rates change, indicating patient deterioration. Validation studies suggest that the EarlySense system records heart and respiratory rate accurately, and that its alerts are predictive of clinical deterioration. One non‑randomised comparative study reported reduced length of stay and fewer intensive care transfers compared with standard monitoring. The system, together with the Vitals software option, costs about £35,000 for a 10‑bed unit and the sensor must be replaced annually at a cost of £475.00 per bed (excluding VAT).

Product summary and likely place in therapy

  • The EarlySense system is a contact‑free continuous measurement system used for routine monitoring of non‑intensive care unit (ICU) hospital patients.

  • Using the Vitals software module, it measures heart rate and respiratory rate and alerts healthcare professionals if these measurements change, helping early identification of patient deterioration.

  • It would be used in non‑critical care wards, in place of manual or separate measurements of heart rate and respiratory rate, where patients may be at risk of deterioration. This can include general (internal) medicine wards, surgical wards, acute medical wards or care wards for older people.

Effectiveness and safety

  • The published evidence summarised in the briefing comes from 6 studies including a total of 41 children and 8093 adults.

  • Two studies assessed diagnostic accuracy for heart and respiratory rates against standard approaches. In 1 non‑controlled case series with 41 children and 58 adults, EarlySense heart rate accuracy was 91.5% in children and 94.4% in adults in a sleep laboratory setting and 94% in ICU. Respiratory rate accuracy was 91.8% in children and 93.1% in adults in a sleep laboratory setting, and 82.0% in adults in ICU.

  • In another case series of 38 patients in ICU, the heart rate accuracy was 92.1% compared with ECG and the respiratory rate accuracy was 80.1% compared with manual measurements.

  • 1 prospective study including 37 critically ill patients reported that unstable respiration precedes and correlates with respiratory failure. The EarlySense system indicated which patients would have a major clinical event in the following 24 hours with 90% specificity and 50% sensitivity.

  • 1 prospective study in 204 patients found that deterioration in clinical condition was detected in 88.6% of incidences and in 100% of major events using EarlySense.

  • 1 prospective study of 113 patients found that EarlySense alerts were infrequent (2.7 and 0.2 alerts per patient‑day for threshold and trend alert respectively). For the threshold alerts, sensitivity and specificity in predicting deterioration was 82% and 67% respectively, for heart rate (HR) and 64% and 81%, respectively, for respiratory rate (RR). For trend alerts, sensitivity and specificity were 78% and 90% for HR, and 100% and 64% for RR respectively.

  • 1 prospective study of 7643 patients found that use of EarlySense resulted in statistically significant reductions in mean days in ICU and major clinical events compared with a standard care ward.

Technical and patient factors

  • The system is based on a piezoelectric sensor that is placed under the patient's mattress or inside a chair seat cushion and is sensitive to applied mechanical strain. It does not need direct patient‑device contact to function.

  • Measurements and trends in the data are displayed at the bedside and on central displays. High and low threshold alerts for both heart rate and respiration rate can be set for each patient. The system alerts healthcare professionals if these thresholds are exceeded.

Cost and resource use

  • The guideline cost for the EarlySense system using the Vitals software is £35,000 for 10 units (1 unit is needed per bed). This cost includes all sensors, bedside units, a nurse station computer and screen, a gateway computer, software and 4 pagers (with transmitter) for nurse or clinician alerts.

  • The piezoelectric sensor must be replaced annually at a cost of £475.00 per bed.