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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded continuous vital sign monitoring | Sham Comparator | Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators. |
|
| Unblinded continuous vital sign monitoring | Experimental | Continuous ward monitoring with vital signs available to investigators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 48 hours after admission to the normal ward |
| Measure | Description | Time Frame |
|---|---|---|
| Individual components of the composite primary endpoint | Total duration of a SpO2 <85% per hour (minutes per hour) | 48 hours after admission to the normal ward |
| Individual components of the composite primary endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen K Thomsen, MD | Contact | +4940741070215 | kr.thomsen@uke.de | |
| Simon Stemmler, MD | Contact | +4940741066077 | s.stemmler@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Bernd Saugel, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 20251 | Germany |
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Patients will be blinded to group allocation. Clinicians and investigators will be blinded to continuous vital signs in the control group. In the intervention group, clinicians will receive information on vital signs from the study staff. Data analysts are blinded to group allocation.
|
| Blinded continuous vital sign monitoring | Device | Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators. |
|
Total duration of a MAP <60 mmHg per hour (minutes per hour)
| 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) | 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) | 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) | 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) | 48 hours after admission to the normal ward |
| Quantitative metrics of peripheral oxygen saturation | Area under a SpO2 of 85% (SpO2 <85% x min) | 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) | 48 hours after admission to the normal ward |
| Quantitative metrics of peripheral oxygen saturation | Number of SpO2 <85% events per patient | 48 hours after admission to the normal ward |
| Quantitative metrics of peripheral oxygen saturation | Proportion of patients with any SpO2 <85% event | 48 hours after admission to the normal ward |
| Quantitative metrics of peripheral oxygen saturation | Total cumulative duration of SpO2 <85% | 48 hours after admission to the normal ward |
| Quantitative metrics of mean arterial pressure | Area under a MAP of 60 mmHg (mmHg x min) | 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) | 48 hours after admission to the normal ward |
| Quantitative metrics of mean arterial pressure | Number of MAP <60 mmHg events per patient | 48 hours after admission to the normal ward |
| Quantitative metrics of mean arterial pressure | Proportion of patients with any MAP <60 mmHg event | 48 hours after admission to the normal ward |
| Quantitative metrics of mean arterial pressure | Total cumulative duration of MAP <60 mmHg | 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) | 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) | 48 hours after admission to the normal ward |
| Quantitative metrics of heart rate | Time-weighted average bradycardia (<45 bpm x min / total monitoring time) | 48 hours after admission to the normal ward |
| Quantitative metrics of heart rate | Time-weighted average tachycardia (>130 bpm x min / total monitoring time) | 48 hours after admission to the normal ward |
| Quantitative metrics of heart rate | Number of events per patient with heart rate <45 bpm | 48 hours after admission to the normal ward |
| Quantitative metrics of heart rate | Number of events per patient with heart rate >130 bpm | 48 hours after admission to the normal ward |
| Quantitative metrics of heart rate | Proportion of patients with any event with heart rate <45 bpm | 48 hours after admission to the normal ward |
| Quantitative metrics of heart rate | Proportion of patients with any event with heart rate >130 bpm | 48 hours after admission to the normal ward |
| Quantitative metrics of heart rate | Total cumulative duration of heart rate <45 bpm | 48 hours after admission to the normal ward |
| Quantitative metrics of heart rate | Total cumulative duration of heart rate >130 bpm | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Area under a respiratory rate 7/min (<7/min x min) | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Area above a respiratory rate 30/min (>30/min x min) | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Time-weighted average bradypnea (<7/min x min / total monitoring time) | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Time-weighted average tachypnea (>30/min x min / total monitoring time) | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Number of events per patient with respiratory rate <7/min | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Number of events per patient with respiratory rate >30/min | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Proportion of patients with any event with respiratory rate <7/min | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Proportion of patients with any event with respiratory rate >30/min | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Total cumulative duration of respiratory rate <7/min | 48 hours after admission to the normal ward |
| Quantitative metrics of respiratory rate | Total cumulative duration of respiratory rate >30/min | 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:
| 48 hours after admission to the normal ward |
| 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. | 30 days after index surgery |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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