Actively Recruiting

Phase Not Applicable
Age: 45Years +
All Genders
ID07385092

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

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Loading map...

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

Similar Trials

Effect of ANNE One-Wellue Device Array Use on Staff Bedside ...

Vital Sign Evaluation

Actively Recruiting

2 locations

Effect of Perioperative Low-dose EsketaMine on Delirium in H...

Delirium in Old Age

Actively Recruiting

6 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here