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.

Recruiting now

Conditions studied: Postoperative Complication, Respiratory Complications, Cardiac Complications

In brief

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.

Key facts

Study ID

NCT07729891

Run by

Azienda Ospedaliero-Universitaria di Parma

People needed

150

Starts

2026-02-10

Expected to finish

2027-02-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to give informed consent and consent to the processing of personal data by signing the relevant forms;
• Aged over 18 years old
• Medium-to-high complexity urological surgery without the need for post-operative monitoring in the Intensive Care Unit
• Surgery performed under general anaesthesia
• Discharge to the ward is scheduled upon leaving the operating theatre

You may not qualify if…

• Refusal or inability to consent to participation
• Patients under 18 years old
• Planned admission to Post-Operative Intensive Care Unit after the surgery
• Unplanned admission to the Post-Operative Intensive Care Unit at the end of the surgery
• Anaesthetic technique other than general anaesthesia.

Where it is running

• 2^ Anestesia, Rianimazione, Terapia Intensiva - Azienda Ospedaliero Universitaria di Parma — Parma, Parma, Italy (enrolling)

Full record on ClinicalTrials.gov

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