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Vital Sign MonitoringCOME ON NOWNCT07385092

Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery

A study testing Unblinded continuous vital sign monitoring and Blinded continuous vital sign monitoring in people with Vital Sign Monitoring and Post Operative Complications, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The "COME ON, NOW!" trial is a randomized, single-center trial in patients recovering from non-cardiac surgery on normal wards investigating whether continuous vital sign monitoring - compared to routine spot-checks by nurses - reduces the total duration of abnormal vital signs per hour during the first 48 hours after… Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
Unblinded continuous vital sign monitoring and Blinded continuous vital sign monitoring
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
264 participants
Where
1 siteGermany
Study dates
24 Feb 2026to 31 Dec 2026
Phase
Interventional
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristen K Thomsen, MD contact

+4940741070215

kr.thomsen@uke.de

Simon Stemmler, MD contact

+4940741066077

s.stemmler@uke.de

Germany1 site, 1 recruiting
  • University Medical Center Hamburg-Eppendorf

    Hamburg, Free and Hanseatic City of Hamburg, 20251

    Kristen K Thomsen, MD, +4940741070215, kr.thomsen@uke.de

    Simon Stemmler, MD, +4940741066077, s.stemmler@uke.de

    Recruiting

Other trials in Germany

About this study

Official title: 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

The "COME ON, NOW!" trial is a randomized, single-center trial in patients recovering from non-cardiac surgery on normal wards investigating whether continuous vital sign monitoring - compared to routine spot-checks by nurses - reduces the total duration of abnormal vital signs per hour during the first 48 hours after admission to the normal ward.

Read the detailed description

"Surgery went well, and everything is fine. Your relative is still in the operating room, but you can visit her/him this afternoon on the normal ward." Each day, thousands of patient families receive relieving calls like this. A call better reflecting clinical reality would be: "Surgery went well, and everything is fine so far - but the most dangerous time is still ahead. The postoperative period poses a much higher risk for patients than surgery itself." Indeed, rates of major postoperative complications and death remain frighteningly high. If the month after surgery were considered a disease, it would be the third leading cause of death worldwide. Most major complications and deaths occur during the initial hospitalization, under direct medical care.

Postoperative deterioration is usually preceded by changes in vital signs minutes to hours earlier. However, these alterations are frequently missed because vital signs on normal wards are typically assessed only every 4-8 hours. Continuous monitoring may allow earlier detection of instability and enable timely interventions to prevent or mitigate serious complications.

The investgators therefore propose a single-center randomized trial in adults recovering from major non-cardiac surgery on normal wards to compare continuous postoperative vital sign monitoring with routine intermittent spot-checks. Patients will be randomized to blinded or unblinded continuous monitoring using a wearable, wireless sensor system (Radius VSM, Masimo, Irvine, CA). In the unblinded group, clinicians will receive real-time alerts.

The primary outcome will be the cumulative duration of vital sign abnormalities during the first 48 hours on the ward. Secondary outcomes will include clinical interventions triggered by these abnormalities. Exploratorily, the investigators will assess a composite of serious in-hospital complications.

Our long-term goal is to reduce postoperative morbidity and mortality by enabling earlier recognition of clinical deterioration and timely intervention on general wards.

Being tested
Unblinded continuous vital sign monitoring, Blinded continuous vital sign monitoring
Keywords
continuous vital signs, vital signs, vital sign monitoring, post-operative care, anesthesiology, anesthesia, hypotension, post-operative complications
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Unblinded continuous vital sign monitoringDevice

    Continuous ward monitoring with vital signs available to investigators. Oxygen saturation, blood pressure (intermittent in intervals of 60 minutes), heart rate, and respiratory rate will be continuously measured and streamed to the investigators (specifically, to a central monitor). The investigators will alert nurses or physicians when SpO2 is <85% for ≥2 minutes, respiratory rate is <7/min or >30/min for ≥2 minutes, MAP is <60 mmHg, or heart rate is <45 bpm or >130 bpm for ≥2 minutes, or in case of apnea for ≥1 minute - supplemented by clinical judgement and the complete electronic record. Investigators will alert clinicians when concerning patterns are identified, whether or not alerts have been triggered. Clinicians will determine if response is necessary and what interventions might be appropriate.

  • Blinded continuous vital sign monitoringDevice

    Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.

Study groups in NCT07385092
Study groupRoleWhat they receive
Blinded continuous vital sign monitoringSham comparatorContinuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
Receives: Device: Blinded continuous vital sign monitoring
Unblinded continuous vital sign monitoringExperimentalContinuous ward monitoring with vital signs available to investigators.
Receives: Device: Unblinded continuous vital sign monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total duration of abnormal vital signs

    Total duration of abnormal vital signs per hour (minutes per hour) during the first 48 hours after admission to the normal ward, i.e., the minutes per hour patients have any of the following abnormal vital signs ("any versus none"): peripheral oxygen saturation (SpO2) <85%, mean arterial pressure (MAP) <60 mmHg, heart rate <45 bpm or >130 bpm, and respiratory rate <7/min or >30/min.

    Measured: 48 hours after admission to the normal ward

Secondary outcomes (37)
  1. Individual components of the composite primary endpoint

    Total duration of a SpO2 <85% per hour (minutes per hour)

    Measured: 48 hours after admission to the normal ward

  2. Individual components of the composite primary endpoint

    Total duration of a MAP <60 mmHg per hour (minutes per hour)

    Measured: 48 hours after admission to the normal ward

  3. Individual components of the composite primary endpoint

    Total duration of a heart rate <45 bpm per hour (minutes per hour)

    Measured: 48 hours after admission to the normal ward

  4. Individual components of the composite primary endpoint

    Total duration of a heart rate >130 bpm per hour (minutes per hour)

    Measured: 48 hours after admission to the normal ward

  5. Individual components of the composite primary endpoint

    Total duration of a respiratory rate <7/min per hour (minutes per hour)

    Measured: 48 hours after admission to the normal ward

  6. Individual components of the composite primary endpoint

    Total duration of a respiratory rate >30/min per hour (minutes per hour)

    Measured: 48 hours after admission to the normal ward

  7. Quantitative metrics of peripheral oxygen saturation

    Area under a SpO2 of 85% (SpO2 <85% x min)

    Measured: 48 hours after admission to the normal ward

  8. Quantitative metrics of peripheral oxygen saturation

    Time-weighted average hypoxemia (SpO2 <85% x min / total monitoring time)

    Measured: 48 hours after admission to the normal ward

  9. Quantitative metrics of peripheral oxygen saturation

    Number of SpO2 <85% events per patient

    Measured: 48 hours after admission to the normal ward

  10. Quantitative metrics of peripheral oxygen saturation

    Proportion of patients with any SpO2 <85% event

    Measured: 48 hours after admission to the normal ward

  11. Quantitative metrics of peripheral oxygen saturation

    Total cumulative duration of SpO2 <85%

    Measured: 48 hours after admission to the normal ward

  12. Quantitative metrics of mean arterial pressure

    Area under a MAP of 60 mmHg (mmHg x min)

    Measured: 48 hours after admission to the normal ward

  13. Quantitative metrics of mean arterial pressure

    Time-weighted average hypotension (MAP <60 mmHg x min / total monitoring time)

    Measured: 48 hours after admission to the normal ward

  14. Quantitative metrics of mean arterial pressure

    Number of MAP <60 mmHg events per patient

    Measured: 48 hours after admission to the normal ward

  15. Quantitative metrics of mean arterial pressure

    Proportion of patients with any MAP <60 mmHg event

    Measured: 48 hours after admission to the normal ward

  16. Quantitative metrics of mean arterial pressure

    Total cumulative duration of MAP <60 mmHg

    Measured: 48 hours after admission to the normal ward

  17. Quantitative metrics of heart rate

    Area under a heart rate of 45 bpm (<45 bpm x min)

    Measured: 48 hours after admission to the normal ward

  18. Quantitative metrics of heart rate

    Area above a heart rate of 130 bpm (>130 bpm x min)

    Measured: 48 hours after admission to the normal ward

  19. Quantitative metrics of heart rate

    Time-weighted average bradycardia (<45 bpm x min / total monitoring time)

    Measured: 48 hours after admission to the normal ward

  20. Quantitative metrics of heart rate

    Time-weighted average tachycardia (>130 bpm x min / total monitoring time)

    Measured: 48 hours after admission to the normal ward

  21. Quantitative metrics of heart rate

    Number of events per patient with heart rate <45 bpm

    Measured: 48 hours after admission to the normal ward

  22. Quantitative metrics of heart rate

    Number of events per patient with heart rate >130 bpm

    Measured: 48 hours after admission to the normal ward

  23. Quantitative metrics of heart rate

    Proportion of patients with any event with heart rate <45 bpm

    Measured: 48 hours after admission to the normal ward

  24. Quantitative metrics of heart rate

    Proportion of patients with any event with heart rate >130 bpm

    Measured: 48 hours after admission to the normal ward

  25. Quantitative metrics of heart rate

    Total cumulative duration of heart rate <45 bpm

    Measured: 48 hours after admission to the normal ward

  26. Quantitative metrics of heart rate

    Total cumulative duration of heart rate >130 bpm

    Measured: 48 hours after admission to the normal ward

  27. Quantitative metrics of respiratory rate

    Area under a respiratory rate 7/min (<7/min x min)

    Measured: 48 hours after admission to the normal ward

  28. Quantitative metrics of respiratory rate

    Area above a respiratory rate 30/min (>30/min x min)

    Measured: 48 hours after admission to the normal ward

  29. Quantitative metrics of respiratory rate

    Time-weighted average bradypnea (<7/min x min / total monitoring time)

    Measured: 48 hours after admission to the normal ward

  30. Quantitative metrics of respiratory rate

    Time-weighted average tachypnea (>30/min x min / total monitoring time)

    Measured: 48 hours after admission to the normal ward

  31. Quantitative metrics of respiratory rate

    Number of events per patient with respiratory rate <7/min

    Measured: 48 hours after admission to the normal ward

  32. Quantitative metrics of respiratory rate

    Number of events per patient with respiratory rate >30/min

    Measured: 48 hours after admission to the normal ward

  33. Quantitative metrics of respiratory rate

    Proportion of patients with any event with respiratory rate <7/min

    Measured: 48 hours after admission to the normal ward

  34. Quantitative metrics of respiratory rate

    Proportion of patients with any event with respiratory rate >30/min

    Measured: 48 hours after admission to the normal ward

  35. Quantitative metrics of respiratory rate

    Total cumulative duration of respiratory rate <7/min

    Measured: 48 hours after admission to the normal ward

  36. Quantitative metrics of respiratory rate

    Total cumulative duration of respiratory rate >30/min

    Measured: 48 hours after admission to the normal ward

  37. The incidence of a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, bradycardia, and hypotension.

    Clinical responses will be considered interventions if:

    1. they are documented in the medical record, and
    2. meet at least one of the following criteria:
    • Respiratory treatment if preceded within 2 hours by SpO2 <85% or respiratory rate <7/min and investigator alert: oxygen, inhaled bronchodilators, naloxone, diuretics, and ventilatory support.
    • Tachycardia interventions preceded within 2 hours by a heart rate of >130 bpm and investigator alert, excluding chronically used preoperative medications: beta-blockers, calcium channel blockers, amiodarone, adenosine, and cardioversion.
    • Bradycardia interventions preceded within 2 hours by a heart rate <45 bpm and investigator alert: Isoproterenol, atropine, glycopyrrolate, epinephrine, cardiac pacing, cardioversion.
    • Hypotension interventions preceded within 2 hours by a mean arterial pressure <60 mmHg and investigator alerts: crystalloids, colloids, norepinephrine, albumin.
    • Any activation of the rapid response team or ICU transfer.

    Measured: 48 hours after admission to the normal ward

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2026
  2. Study start24 Feb 2026
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07385092
Sponsor's protocol ID
2023-101178-BO-ff
Other IDs
2023
Acronym
COME ON NOW
Status last verified
Feb 2026
First submitted
13 Jan 2026
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Unblinded continuous vital sign monitoring and Blinded continuous vital sign monitoring in people with Vital Sign Monitoring and Post Operative Complications, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

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 1 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 2 Mar 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 Germany. 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. Some participants in this study may receive a placebo. 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 Kristen K Thomsen, MD (+4940741070215, kr.thomsen@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total duration of abnormal vital signs (time frame: 48 hours after admission to the normal ward). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Mar 2026.

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