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.

NCT07729891 | Recruiting FDA Device

• 1 other identifier: 421/2024/DISP/AOUPR
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Complication; Respiratory Complications; Cardiac Complications

Keywords

postoperative; complications; intensive care unit admission; urology; wearable devices; continuous monitoring; surgical ward; wireless; medical emergency team; unplanned ICU admission

Outcome Measures

Primary Outcomes (3)

• Number of event of desaturation

  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

  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

  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 Outcomes (7)

• False-positive rate

  72 hours after the surgery

• Number of on-call doctor call-outs

  72 hours after the surgery

• Number of requests for Anesthesia consultation

  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)

  72 hours after surgery

• Occurrence of post-surgical complications (any type) or reoperation

  72 hours after surgery or patients discharge

Study Arms (2)

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

Interventions

Continuous vital sign monitoring with Portrait Mobile in surgical ward DEVICE

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.

Wearable device continuous vital sign monitoring (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Parma: lead

Study Sites (1)

2^ Anestesia, Rianimazione, Terapia Intensiva - Azienda Ospedaliero Universitaria di Parma

Parma, Parma, 43126, Italy

RECRUITING

Related Publications (14)

• Thompson JS, Baxter BT, Allison JG, Johnson FE, Lee KK, Park WY. Temporal patterns of postoperative complications. Arch Surg. 2003 Jun;138(6):596-602; discussion 602-3. doi: 10.1001/archsurg.138.6.596.

  PMID: 12799329 BACKGROUND

• Levin N, Horton D, Sanford M, Horne B, Saseendran M, Graves K, White M, Tonna JE. Failure of vital sign normalization is more strongly associated than single measures with mortality and outcomes. Am J Emerg Med. 2020 Dec;38(12):2516-2523. doi: 10.1016/j.ajem.2019.12.024. Epub 2019 Dec 14.

  PMID: 31864869 BACKGROUND

• Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.

  PMID: 23295778 BACKGROUND

• Bellini V, Brambilla M, Bignami E. Wearable devices for postoperative monitoring in surgical ward and the chain of liability. J Anesth Analg Crit Care. 2024 Mar 7;4(1):19. doi: 10.1186/s44158-024-00154-6.

  PMID: 38454498 BACKGROUND

• Downey CL, Croft J, Ainsworth G, Buckley H, Shinkins B, Randell R, Brown JM, Jayne DG. Trial of remote continuous versus intermittent NEWS monitoring after major surgery (TRaCINg): a feasibility randomised controlled trial. Pilot Feasibility Stud. 2020 Nov 23;6(1):183. doi: 10.1186/s40814-020-00709-8.

  PMID: 33292669 BACKGROUND

• Churpek MM, Yuen TC, Park SY, Gibbons R, Edelson DP. Using electronic health record data to develop and validate a prediction model for adverse outcomes in the wards*. Crit Care Med. 2014 Apr;42(4):841-8. doi: 10.1097/CCM.0000000000000038.

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• Nagendran M, Dimick JB, Gonzalez AA, Birkmeyer JD, Ghaferi AA. Mortality Among Older Adults Before Versus After Hospital Transition to Intensivist Staffing. Med Care. 2016 Jan;54(1):67-73. doi: 10.1097/MLR.0000000000000446.

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• van der Stam JA, Mestrom EHJ, Nienhuijs SW, de Hingh IHJT, Boer AK, van Riel NAW, de Groot KTJ, Verhaegh W, Scharnhorst V, Bouwman RA. A wearable patch based remote early warning score (REWS) in major abdominal cancer surgery patients. Eur J Surg Oncol. 2023 Jan;49(1):278-284. doi: 10.1016/j.ejso.2022.08.034. Epub 2022 Sep 2.

  PMID: 36085116 BACKGROUND

• Lee A, Lum ME, O'Regan WJ, Hillman KM. Early postoperative emergencies requiring an intensive care team intervention. The role of ASA physical status and after-hours surgery. Anaesthesia. 1998 Jun;53(6):529-35. doi: 10.1046/j.1365-2044.1998.00395.x.

  PMID: 9709136 BACKGROUND

• Khanna AK, Flick M, Saugel B. Continuous vital sign monitoring of patients recovering from surgery on general wards: a narrative review. Br J Anaesth. 2025 Feb;134(2):501-509. doi: 10.1016/j.bja.2024.10.045. Epub 2025 Jan 7.

  PMID: 39779421 BACKGROUND

• Breteler MJM, KleinJan E, Numan L, Ruurda JP, Van Hillegersberg R, Leenen LPH, Hermans M, Kalkman CJ, Blokhuis TJ. Are current wireless monitoring systems capable of detecting adverse events in high-risk surgical patients? A descriptive study. Injury. 2020 May;51 Suppl 2:S97-S105. doi: 10.1016/j.injury.2019.11.018. Epub 2019 Nov 17.

  PMID: 31761422 BACKGROUND

• Lam T, Nagappa M, Wong J, Singh M, Wong D, Chung F. Continuous Pulse Oximetry and Capnography Monitoring for Postoperative Respiratory Depression and Adverse Events: A Systematic Review and Meta-analysis. Anesth Analg. 2017 Dec;125(6):2019-2029. doi: 10.1213/ANE.0000000000002557.

  PMID: 29064874 BACKGROUND

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  PMID: 18443635 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Valentina Bellini

CONTACT

+393388284629; bellini.vnt@gmail.com

Matteo Panizzi

CONTACT

+393494156020; matteo.panizzi@unipr.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 28, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of enrollment and data collection
• Access Criteria: Upon request to the Principal Investigator

Locations

IT (1)