An interventional study of Unblinded continuous vital sign monitoring and Blinded continuous vital sign monitoring in Vital Sign Monitoring, Post Operative Complications and Non-cardiac Surgery, sponsored by Universitätsklinikum Hamburg-Eppendorf. Recruiting at 1 site in Germany. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
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.
"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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 264 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
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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:
Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
Device: Blinded continuous vital sign monitoring
Continuous ward monitoring with vital signs available to investigators.
Device: Unblinded continuous vital sign monitoring
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.
Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
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.
Time frame: 48 hours after admission to the normal ward
Individual components of the composite primary endpoint
Total duration of a SpO2 \<85% per hour (minutes per hour)
Time frame: 48 hours after admission to the normal ward
Individual components of the composite primary endpoint
Total duration of a MAP \<60 mmHg per hour (minutes per hour)
Time frame: 48 hours after admission to the normal ward
Individual components of the composite primary endpoint
Total duration of a heart rate \<45 bpm per hour (minutes per hour)
Time frame: 48 hours after admission to the normal ward
Individual components of the composite primary endpoint
Total duration of a heart rate \>130 bpm per hour (minutes per hour)
Time frame: 48 hours after admission to the normal ward
Individual components of the composite primary endpoint
Total duration of a respiratory rate \<7/min per hour (minutes per hour)
Time frame: 48 hours after admission to the normal ward
Individual components of the composite primary endpoint
Total duration of a respiratory rate \>30/min per hour (minutes per hour)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of peripheral oxygen saturation
Area under a SpO2 of 85% (SpO2 \<85% x min)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of peripheral oxygen saturation
Time-weighted average hypoxemia (SpO2 \<85% x min / total monitoring time)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of peripheral oxygen saturation
Number of SpO2 \<85% events per patient
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of peripheral oxygen saturation
Proportion of patients with any SpO2 \<85% event
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of peripheral oxygen saturation
Total cumulative duration of SpO2 \<85%
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of mean arterial pressure
Area under a MAP of 60 mmHg (mmHg x min)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of mean arterial pressure
Time-weighted average hypotension (MAP \<60 mmHg x min / total monitoring time)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of mean arterial pressure
Number of MAP \<60 mmHg events per patient
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of mean arterial pressure
Proportion of patients with any MAP \<60 mmHg event
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of mean arterial pressure
Total cumulative duration of MAP \<60 mmHg
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Area under a heart rate of 45 bpm (\<45 bpm x min)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Area above a heart rate of 130 bpm (\>130 bpm x min)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Time-weighted average bradycardia (\<45 bpm x min / total monitoring time)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Time-weighted average tachycardia (\>130 bpm x min / total monitoring time)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Number of events per patient with heart rate \<45 bpm
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Number of events per patient with heart rate \>130 bpm
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Proportion of patients with any event with heart rate \<45 bpm
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Proportion of patients with any event with heart rate \>130 bpm
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Total cumulative duration of heart rate \<45 bpm
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of heart rate
Total cumulative duration of heart rate \>130 bpm
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Area under a respiratory rate 7/min (\<7/min x min)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Area above a respiratory rate 30/min (\>30/min x min)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Time-weighted average bradypnea (\<7/min x min / total monitoring time)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Time-weighted average tachypnea (\>30/min x min / total monitoring time)
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Number of events per patient with respiratory rate \<7/min
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Number of events per patient with respiratory rate \>30/min
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Proportion of patients with any event with respiratory rate \<7/min
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Proportion of patients with any event with respiratory rate \>30/min
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Total cumulative duration of respiratory rate \<7/min
Time frame: 48 hours after admission to the normal ward
Quantitative metrics of respiratory rate
Total cumulative duration of respiratory rate \>30/min
Time frame: 48 hours after admission to the normal ward
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.
Time frame: 48 hours after admission to the normal ward
Composite of serious in-hospital complications
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.
Time frame: 48 hours after admission to the normal ward
Time-to-event endpoint
Time-to-event endpoint with the event "hospital discharge" within 30 days after surgery.
Time frame: 30 days after index surgery
Plan to share: No
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Universitätsklinikum Hamburg-Eppendorf