Continuous wearable vital-sign monitoring versus routine spot-checks after non-cardiac surgery
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
This trial will test whether continuous wearable vital-sign monitoring can reduce the time abnormal signs go unnoticed in adults recovering on regular wards after major non-cardiac surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Trial ID | NCT07385092 on ClinicalTrials.gov |
What this trial studies
This is a randomized, single-center trial in adults recovering from major elective non-cardiac (abdominal or thoracic) surgery who are admitted to a normal ward after an initial post-anesthesia stay. Participants are randomized to different implementations of continuous monitoring using a wearable, wireless sensor system (Radius VSM), with monitoring either visible or blinded to ward staff. The primary outcome is the total duration of abnormal vital signs per hour during the first 48 hours after admission to the normal ward. The goal is to determine whether continuous wearable monitoring shortens the time physiologic instability is present and undetected compared with current intermittent checks.
Who should consider this trial
Good fit: Adults aged 45 years or older scheduled for elective major non-cardiac (abdominal or thoracic) surgery with planned postoperative admission to a normal ward are the intended candidates.
Not a fit: Patients undergoing emergency surgery, pregnant patients, those with atrial fibrillation, those who cannot be monitored with the Radius VSM sensor, or patients designated DNR/receiving end-of-life care are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, continuous monitoring could allow earlier recognition of deterioration and reduce the time abnormal vital signs go unrecognized, potentially preventing complications.
How similar studies have performed: Previous studies of continuous ward monitoring have shown feasibility and earlier detection of physiologic changes, but randomized evidence that this consistently reduces major complications or mortality remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Consenting patients ≥45 years scheduled for elective non-cardiac (abdominal and thoracic) surgery with planned postoperative admission to a normal ward after an overnight stay in an advanced post-anesthesia care unit. Exclusion Criteria: * Emergency surgery * Pregnancy * Impossibility to perform continuous monitoring with the Radius VSM sensor (Masimo, Irvine, CA) * Atrial fibrillation * Patients designated Do Not Resuscitate, or are receiving end-of-life care
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg
- University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Bernd Saugel, MD — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Kristen K Thomsen, MD
- Email: kr.thomsen@uke.de
- Phone: +4940741070215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.