Real-time Evaluation and Continuous Observation of Vital Signs for Enhanced Recovery: a Study for the Early Identification of Complications in the Surgical Ward Following Surgery in Patients Not Eligible for Intensive Care Admission.

Condition(s) studied

Investigational drug(s) / intervention(s)

Continuous vital sign monitoring with Portrait Mobile in surgical ward: The wearable system is applied on the evening before surgery so that baseline vital sign values can be collected under resting conditions. Monitoring is interrupted before transfer to the operating room and restarted after the patient returns from surgery to the ward. The patient then wears the system for at least 72 hours after surgery. Respiratory rate, oxygen saturation, and heart rate are continuously collected, while blood pressure and EKG continues to be measured intermittently according to usual ward practice in order to maintain the non-intensive care settings and the actual patient-nurse ratio. Alarm thresholds are predefined by the investigator using values derived from NEWS and alarms calibrated over baseline parameters.

Study summary

This study aims to evaluate whether continuous vital sign monitoring with wearable devices can help detect postoperative complications in surgical ward earlier than standard hospital monitoring. In particular, the goal of this observational study is to evaluate if the wireless wearable devices Portrait Mobile (GE Healthcare) can detect early signs of complications after major urologic surgery in adults who are not eligible for intensive care unit admission. The main questions it aims to answer are:

* Can continuous monitoring of vital signs (heart rate, breathing rate, blood oxygen) detect health problems earlier than standard nurse checks in the urology ward?
* How many times do participants' vital signs change in ways that suggest a complication is developing during the first days after surgery?
* Does the vital sign trend and/or the deviation from patients' baseline suggest a complication is developing during the first days after surgery?
* Does continuous monitoring help healthcare providers intervene before patients become critically ill thus reducing complications burden or severity and reducing unplanned intensive care admission? Participants in the intervention cohort will wear a wireless patch-like device on their chest that continuously tracks their heart rate, breathing rate, and blood oxygen levels. The device sends this information to hospital staff through a secure wireless connection while participants recover in the regular urology ward after surgery. Participants in the intervention cohort will wear the device for 3 days after surgery or until they leave the hospital. Healthcare providers will receive alerts if vital signs change in ways that suggest a complication may be developing. This may help providers treat problems earlier and prevent patients from becoming critically ill. All participants will also receive standard post-surgical care, including regular nurse checks of vital signs.

Eligibility

Primary outcome measure(s)

• Number of event of desaturation — 72 hours after the surgery
  An 'event' among the primary outcomes will be those used by the National Early Warning System Score (NEWS: Respiratory rate \<11 and \>21 breaths/min; SpO₂ \<95%; Heart rate \<50 bpm and \>91 bpm)
• Number of event of tachypnoea or bradypnoea — 72 hours after the surgery
  An 'event' among the primary outcomes will be those used by the National Early Warning System Score (NEWS: Respiratory rate \<11 and \>21 breaths/min; SpO₂ \<95%; Heart rate \<50 bpm and \>91 bpm)
• Number of event of haemodinamic instability — 72 hours after the surgery
  An 'event' among the primary outcomes will be those used by the National Early Warning System Score (NEWS: Respiratory rate \<11 and \>21 breaths/min; SpO₂ \<95%; Heart rate \<50 bpm and \>91 bpm)

Trial sites (1)

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