Postoperative ComplicationRECOVERNCT07729891
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.
An observational study of Postoperative Complication and Respiratory Complications, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complication, Respiratory Complications, Cardiac Complications
- What is being tested?
- Continuous vital sign monitoring with Portrait Mobile in surgical ward
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing to major urological surgery performed under general anesthesia and without a planned intensive care unit admission.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
2^ Anestesia, Rianimazione, Terapia Intensiva - Azienda Ospedaliero Universitaria di Parma
Parma, Parma, 43126
Valentina Bellini, +393388284629, bellini.vnt@gmail.com
Matteo Panizzi, +393494156020, matteo.panizzi@unipr.it
About this study
Official title: 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.
Read the 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.
- Being tested
- Continuous vital sign monitoring with Portrait Mobile in surgical ward
- Keywords
- postoperative, complications, intensive care unit admission, urology, wearable devices, continuous monitoring, surgical ward, wireless, medical emergency team, unplanned ICU admission
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous vital sign monitoring with Portrait Mobile in surgical wardDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continuous vital sign monitoring with Portrait Mobile in surgical ward |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 72 hours after the surgery
Secondary outcomes (7)
False-positive rate
Number of alarms triggered without a real Event
Measured: 72 hours after the surgery
Number of on-call doctor call-outs
Nurse activation of the medical staff of the surgery ward
Measured: 72 hours after the surgery
Number of requests for Anesthesia consultation
Activation of Hospital medical emergency team
Measured: 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)
After Anesthesiological evaluation and activation of Hospital medical emergency team
Measured: 72 hours after surgery
Occurrence of post-surgical complications (any type) or reoperation
Any type of complication and their severity (Clavien Dindo score) that occur during the intervention period
Measured: 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.
To investigate the incidence of complication and/or prolonged LOS if the patient experience a progressive postoperative deviation from baseline vital parameters.
Measured: Untill patient discharge from hospital
Barriers to patient rehabilitation and patients satisfaction
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.
Measured: 72 hours after surgery or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start10 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Bellini, Azienda Ospedaliero-Universitaria di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729891
- Sponsor's protocol ID
- 421/2024/DISP/AOUPR
- Acronym
- RECOVER
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Raw IPD that underlie results
Publications
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.
PubMed 12799329Levin 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.
PubMed 31864869Smith 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.
PubMed 23295778Bellini 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.
PubMed 38454498Downey 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.
PubMed 33292669Churpek 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.
PubMed 24247472Nagendran 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.
PubMed 26492215van 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.
PubMed 36085116Lee 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.
PubMed 9709136Khanna 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.
PubMed 39779421Breteler 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.
PubMed 31761422Lam 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.
PubMed 29064874Stone JG, Cozine KA, Wald A. Nocturnal oxygenation during patient-controlled analgesia. Anesth Analg. 1999 Jul;89(1):104-10. doi: 10.1097/00000539-199907000-00018.
PubMed 10389786Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
PubMed 18443635
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Evaluation and Continuous Observation of Vital Signs for Enhanced Recovery
- ClinicalTrials.gov ID
- NCT07729891
- Acronym / sponsor ID
- RECOVER / 421/2024/DISP/AOUPR
- Keywords
- postoperative, complications, intensive care unit admission, urology, wearable devices, continuous monitoring, surgical ward, wireless
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ParmaUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard intermittent monitoring (Control) | – | –100 patients receiving standard intermittent nurse vital sign check |
| Wearable device continuous vital sign monitoring (Intervention) | – | Device: Continuous vital sign monitoring with Portrait Mobile in surgical ward50 patients receiving wearable device continuous vital sign monitoring with Portrait Mobile (GE Healthcare). Parameters monitored: Heart Rate, SpO2, Respiratory Rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing to major urological surgery performed under general anesthesia and without a planned intensive care unit admission.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous vital sign monitoring with Portrait Mobile in surgical wardThe 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. | Device | Wearable device continuous vital sign monitoring (Intervention) |
Primary outcome
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)
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)
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)
7 secondary outcomes
False-positive rate
Time frame: 72 hours after the surgery
Number of on-call doctor call-outs
Time frame: 72 hours after the surgery
Number of requests for Anesthesia consultation
Time frame: 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
Occurrence of post-surgical complications (any type) or reoperation
Time frame: 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
Barriers to patient rehabilitation and patients satisfaction
Time frame: 72 hours after surgery or discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 12799329Thompson 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.
- Background: PubMed 31864869Levin 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.
- Background: PubMed 23295778Smith 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.
- Background: PubMed 38454498Bellini 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.
- Background: PubMed 33292669Downey 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.
- Background: PubMed 24247472Churpek 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.
- Background: PubMed 26492215Nagendran 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.
- Background: PubMed 36085116van 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.
- Background: PubMed 9709136Lee 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.
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- Individual participant dataSharing planned: Yes. Raw IPD that underlie results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complication and Respiratory Complications, run by Azienda Ospedaliero-Universitaria di Parma at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Bellini (+393388284629, bellini.vnt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of event of desaturation (time frame: 72 hours after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07729891, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.