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NCT Number: NCT07385092

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

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.

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Key information

Conditions

Vital Sign Monitoring Anesthesiology Cardiovascular Diseases Hypotension Non-cardiac Surgery Post Operative Complications RCT Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unblinded continuous vital sign monitoring

Device

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 monitoring

Device

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

Primary outcomes

  1. Total duration of abnormal vital signs

    Time frame: 48 hours after admission to the normal ward

    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.

Secondary outcomes

  1. Individual components of the composite primary endpoint

    Time frame: 48 hours after admission to the normal ward

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

  2. Individual components of the composite primary endpoint

    Time frame: 48 hours after admission to the normal ward

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

  3. Individual components of the composite primary endpoint

    Time frame: 48 hours after admission to the normal ward

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

  4. Individual components of the composite primary endpoint

    Time frame: 48 hours after admission to the normal ward

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

  5. Individual components of the composite primary endpoint

    Time frame: 48 hours after admission to the normal ward

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

  6. Individual components of the composite primary endpoint

    Time frame: 48 hours after admission to the normal ward

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

  7. Quantitative metrics of peripheral oxygen saturation

    Time frame: 48 hours after admission to the normal ward

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

  8. Quantitative metrics of peripheral oxygen saturation

    Time frame: 48 hours after admission to the normal ward

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

  9. Quantitative metrics of peripheral oxygen saturation

    Time frame: 48 hours after admission to the normal ward

    Number of SpO2 <85% events per patient

  10. Quantitative metrics of peripheral oxygen saturation

    Time frame: 48 hours after admission to the normal ward

    Proportion of patients with any SpO2 <85% event

  11. Quantitative metrics of peripheral oxygen saturation

    Time frame: 48 hours after admission to the normal ward

    Total cumulative duration of SpO2 <85%

  12. Quantitative metrics of mean arterial pressure

    Time frame: 48 hours after admission to the normal ward

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

  13. Quantitative metrics of mean arterial pressure

    Time frame: 48 hours after admission to the normal ward

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

  14. Quantitative metrics of mean arterial pressure

    Time frame: 48 hours after admission to the normal ward

    Number of MAP <60 mmHg events per patient

  15. Quantitative metrics of mean arterial pressure

    Time frame: 48 hours after admission to the normal ward

    Proportion of patients with any MAP <60 mmHg event

  16. Quantitative metrics of mean arterial pressure

    Time frame: 48 hours after admission to the normal ward

    Total cumulative duration of MAP <60 mmHg

  17. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

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

  18. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

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

  19. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

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

  20. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

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

  21. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

    Number of events per patient with heart rate <45 bpm

  22. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

    Number of events per patient with heart rate >130 bpm

  23. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

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

  24. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

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

  25. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

    Total cumulative duration of heart rate <45 bpm

  26. Quantitative metrics of heart rate

    Time frame: 48 hours after admission to the normal ward

    Total cumulative duration of heart rate >130 bpm

  27. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

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

  28. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

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

  29. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

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

  30. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

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

  31. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

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

  32. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

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

  33. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

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

  34. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

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

  35. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

    Total cumulative duration of respiratory rate <7/min

  36. Quantitative metrics of respiratory rate

    Time frame: 48 hours after admission to the normal ward

    Total cumulative duration of respiratory rate >30/min

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

    Time frame: 48 hours after admission to the normal ward

    Clinical responses will be considered interventions if:

    • they are documented in the medical record, and
    • 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.

Other outcomes

  1. Composite of serious in-hospital complications

    Time frame: 48 hours after admission to the normal ward

    The investigators will also record components of our exploratory composite of serious in-hospital complications, including naloxone administration, rapid-response team activation, unplanned ICU transfer, revision surgery, infectious complications, myocardial infarction, stroke, unplanned tracheal intubation, non-fatal cardiac arrest, and death during the first 48 hours after admission to the normal ward and during hospital stay.

  2. Time-to-event endpoint

    Time frame: 30 days after index surgery

    Time-to-event endpoint with the event "hospital discharge" within 30 days after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Kristen K Thomsen, MD

CONTACT

[email protected]

+4940741070215

Simon Stemmler, MD

CONTACT

[email protected]

+4940741066077

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study 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

Acronym: COME ON NOW

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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