A wearable patch based remote early warning score (REWS) in major abdominal cancer surgery patients.
Jonna A van der Stam, Eveline H J Mestrom, Simon W Nienhuijs...
https://pubmed.ncbi.nlm.nih.gov/36085116/Actively Recruiting
Led by Azienda Ospedaliero-Universitaria di Parma · Updated on 2026-07-28
150
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether continuous monitoring of vital signs using wearable devices can help detect complications earlier in adults recovering from major urologic surgery who do not require intensive care. This observational study focuses on whether these devices can identify early signs of problems like desaturation, abnormal breathing rates, and hemodynamic instability sooner than standard intermittent nurse checks in the surgical ward. The study particularly assesses the Portrait Mobile system by GE Healthcare to monitor heart rate, breathing rate, and blood oxygen. Participants in the wearable monitoring group will have the device applied before surgery to collect baseline vital signs at rest. Monitoring pauses during surgery and resumes upon return to the ward, continuing for at least 72 hours after surgery. Meanwhile, standard intermittent monitoring of blood pressure and EKG will continue per usual ward practice. Another group will receive standard care without the wearable device for comparison. Alarms are set based on vital sign thresholds and changes from baseline, alerting staff to possible complications. Participants provide informed consent before surgery during anesthesiology evaluation. Throughout the postoperative period, vital signs are continuously or intermittently measured, and alerts from the wearable device are reviewed by nursing staff who determine their appropriateness and note patient activity. Clinical actions taken in response to alarms are recorded. The study measures the number of events indicating complications, false positives, physician alerts, intensive care consultations, complications, length of hospital stay, patient satisfaction, and integration with hospital systems. The total participation lasts through the hospital stay, with monitoring primarily during the first 72 hours after surgery.
CONDITIONS
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.
V
Valentina Bellini
M
Matteo Panizzi
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Azienda Ospedaliero-Universitaria di Parma
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 preoperative anesthesiology evaluation visit
Duration - 1 day
The wearable device is applied before surgery to collect baseline vital signs. Monitoring is paused during surgery and restarted after the participant returns to the ward.
Device application on evening before surgery and monitoring during surgery day
Duration - At least 3 days after surgery
Participants wear the device continuously for at least 72 hours after surgery to monitor heart rate, breathing, and oxygen levels. Standard intermittent monitoring continues as usual.
Continuous monitoring with device and regular nurse checks
Duration - Until hospital discharge
Clinical actions in response to alarms are recorded, along with postoperative complications, length of hospital stay, and patient satisfaction until discharge.
Data collected during hospital stay
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/33292669/Azienda Ospedaliero-Universitaria di Parma
Lead Sponsor