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. (RECOVER)

July 22, 2026 updated by: Valentina Bellini, Azienda Ospedaliero-Universitaria di Parma

Real-time Evaluation and Continuous Observation of Vital Signs for Enhanced Recovery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The RECOVER study evaluates the use of continuous wearable monitoring in surgical ward for the early detection of postoperative complications in patients recovering after major surgery. The study begins with the evaluation of urologic surgery. It focuses on whether continuous measurement of vital signs in the surgical ward can identify clinical deterioration and postoperative complications earlier than routine postoperative surveillance alone: postoperative complications are often preceded by changes in vital signs and may develop during the first days after surgery, when patients are usually monitored intermittently in the ward. Continuous wireless monitoring is intended to provide earlier recognition of respiratory and hemodynamic deterioration while patients recover outside the operating room and outside intensive care.

The main objective is to assess whether continuous monitoring of vital signs can detect early signs of medical or surgical postoperative complications after moderate-to-high complexity urologic surgery performed under general anesthesia. The protocol is particularly focused on identifying episodes of desaturation, tachypnea, hemodynamic instability, and persistent deviation of vital signs from patient's baseline values during the postoperative period.

Patient enrollment takes place in the Urology ward before the scheduled operation. During the preoperative anesthesiology evaluation, the anesthesiologist provides study information and asks the patient to participate by signing informed consent and personal data processing forms. This enrollment process is maintained in both patient pathways described in the protocol.

For patients managed with continuous monitoring, 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, and the device does not replace standard postoperative monitoring.

The wearable platform used in the protocol is the Portrait Mobile® system by GE HealthCare. It continuously records respiratory rate, oxygen saturation, and heart rate, 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. Data are transmitted through the hospital Wi-Fi network to a dedicated monitoring infrastructure, where alarms can be visualized on the ward monitoring station.

Alarm thresholds are predefined by the investigator using values derived from the National Early Warning System Score. These thresholds include respiratory rate below 11 or above 21 breaths per minute, oxygen saturation below 95%, and heart rate below 50 or above 91 beats per minute. In addition to threshold-based events, the protocol evaluates persistent deviation from baseline, defined as a change greater than 20% for at least 24 hours, in order to capture clinically meaningful trends rather than isolated abnormal values.

When an alarm is generated, ward nursing staff are asked to determine whether the alert is appropriate or represents a false positive. They also record whether the patient is at rest or moving at the time of the alert, allowing the investigators to assess device performance under real clinical conditions. Subsequent clinical actions, including review by the ward physician, on-call physician activation, or request for anesthesiology consultation, are reconstructed from nursing handover and the clinical chart.

For patients managed with usual postoperative surveillance alone, enrollment still occurs during the preoperative anesthesiology assessment and clinical data are collected after informed consent is obtained. These patients receive standard ward monitoring without wearable continuous monitoring, and their postoperative course is documented for comparison of clinical events and outcomes.

The primary endpoints are the number of desaturation events, tachypnea events, and hemodynamic instability events. Secondary endpoints include false positive rate, number of physician alerts, number of requests for intensive care consultation, unplanned intensive care admission directly from the operating area, transfer to intensive care during postoperative ward stay, postoperative complications, re-surgery, correlation between parameter trends and outcomes, hospital length of stay, barriers to rehabilitation, patient satisfaction, and integration of the system with the hospital IT infrastructure.

All complications will be recorded in the case report form and graded according to the Clavien-Dindo classification. Collected data include baseline patient characteristics, average preoperative vital sign values, diagnosis, type of surgery, intraoperative data, continuous monitoring data, postoperative clinical course, pain, functional recovery, total hospital stay, ICU stay, and patient satisfaction with the monitoring system.

The system is not expected to expose patients to additional risk and does not interfere with the usual diagnostic and therapeutic pathway. Wireless wearable monitoring should not negatively affect mobilization, rehabilitation, or functional recovery, which is relevant because preservation of postoperative recovery is one of the practical concerns addressed by the study.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Parma
      • Parma, Parma, Italy, 43126
        • Recruiting
        • 2^ Anestesia, Rianimazione, Terapia Intensiva - Azienda Ospedaliero Universitaria di Parma
        • Contact:
        • Contact:
        • Principal Investigator:
          • Valentina Bellini
        • Sub-Investigator:
          • Matteo Panizzi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing to major urological surgery performed under general anesthesia and without a planned intensive care unit admission.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard intermittent monitoring (Control)
100 patients receiving standard intermittent nurse vital sign check
Wearable device continuous vital sign monitoring (Intervention)
50 patients receiving wearable device continuous vital sign monitoring with Portrait Mobile (GE Healthcare). Parameters monitored: Heart Rate, SpO2, Respiratory Rate.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of event of desaturation
Time Frame: 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)
72 hours after the surgery
Number of event of tachypnoea or bradypnoea
Time Frame: 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)
72 hours after the surgery
Number of event of haemodinamic instability
Time Frame: 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)
72 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
False-positive rate
Time Frame: 72 hours after the surgery
Number of alarms triggered without a real Event
72 hours after the surgery
Number of on-call doctor call-outs
Time Frame: 72 hours after the surgery
Nurse activation of the medical staff of the surgery ward
72 hours after the surgery
Number of requests for Anesthesia consultation
Time Frame: 72 hours after surgery
Activation of Hospital medical emergency team
72 hours after surgery
Unscheduled direct admission to the Intensive Care Unit from the operating theatre and unplanned transfer to the Intensive Care Unit during the post-operative period (from the surgical ward)
Time Frame: 72 hours after surgery
After Anesthesiological evaluation and activation of Hospital medical emergency team
72 hours after surgery
Occurrence of post-surgical complications (any type) or reoperation
Time Frame: 72 hours after surgery or patients discharge
Any type of complication and their severity (Clavien Dindo score) that occur during the intervention period
72 hours after surgery or patients discharge
Correlation between parameters trend, including persistent deviation from pre-operative values, and patient outcome or length of hospital stay.
Time Frame: Untill patient discharge from hospital
To investigate the incidence of complication and/or prolonged LOS if the patient experience a progressive postoperative deviation from baseline vital parameters.
Untill patient discharge from hospital
Barriers to patient rehabilitation and patients satisfaction
Time Frame: 72 hours after surgery or discharge
Investigate whether the wearable device hinders patient rehabilitation, expressed as the percentage of patients reporting a reduced capacity for postoperative early mobilization or rehabilitation, and patients global satisfaction through a questionnaire.
72 hours after surgery or discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 28, 2026

Study Record Updates

Last Update Posted (Actual)

July 28, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 421/2024/DISP/AOUPR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw IPD that underlie results

IPD Sharing Time Frame

At the end of enrollment and data collection

IPD Sharing Access Criteria

Upon request to the Principal Investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe