Actively Recruiting
The Effect of Continuous Monitoring Versus Routine Spot-checks on Altered Vital Signs in Patients Recovering From Non-cardiac Surgery on Normal Wards: the "COME ON, NOW!" Trial
Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2026-03-02
264
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether continuous vital sign monitoring after non-cardiac surgery can reduce the time patients spend with abnormal vital signs compared to routine spot-checks by nurses. This randomized, single-center trial focuses on adults recovering on normal hospital wards, as most serious complications and deaths occur during the early postoperative period when vital sign changes may be missed due to infrequent checks. Participants will be assigned to one of two groups: one with continuous vital sign monitoring using a wearable, wireless sensor where data are recorded but not shared with clinicians, and another group where the same monitoring is unblinded, allowing clinicians to receive real-time alerts for abnormal oxygen levels, heart rate, blood pressure, and respiratory rate. These alerts may prompt timely clinical interventions. The primary evaluation will measure the total duration of abnormal vital signs during the first 48 hours after admission to the normal ward. During the study, patients will have their vital signs monitored continuously with the wearable sensor for 48 hours on the ward. Researchers will analyze clinical interventions triggered by vital sign abnormalities and assess serious in-hospital complications. The study aims to improve early detection of patient deterioration after surgery to reduce complications and improve outcomes. Participation includes monitoring and data collection during the first two days after surgery in the normal ward setting.
CONDITIONS
Brief Title
Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Consenting patients aged 45 years or older
- Scheduled for elective non-cardiac (abdominal and thoracic) surgery
- Planned postoperative admission to a normal ward after an overnight stay in an advanced post-anesthesia care unit
You will not qualify if you...
- Emergency surgery
- Pregnancy
- Unable to perform continuous monitoring with the Radius VSM sensor
- Atrial fibrillation
- Patients designated Do Not Resuscitate or receiving end-of-life care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours
Participants undergo continuous vital sign monitoring on a normal ward after major non-cardiac surgery. Monitoring is either blinded or unblinded using a wearable, wireless sensor system for up to 48 hours to detect changes in vital signs.
Continuous monitoring during hospital stay on the normal ward
Duration - Up to hospital discharge after monitoring period
Participants are observed for clinical interventions and outcomes related to vital sign abnormalities detected during the monitoring period.
Additional assessments may occur depending on clinical course
Trial Site Locations
Total: 1 location
1
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20251
Actively Recruiting
Research Team
K
Kristen K Thomsen, MD
S
Simon Stemmler, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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