Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Unblinded continuous vital sign monitoring, Blinded continuous vital sign monitoring.
- Who it may be relevant to
- Registry conditions: Vital Sign Monitoring, Post Operative Complications, Non-cardiac Surgery, RCT. Basic parameters: from 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- 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 - Device Blinded continuous vital sign monitoring
Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
Primary outcome measures
- Total duration of abnormal vital signs [Time frame: 48 hours after admission to the normal ward]
Secondary outcome measures (12)
- Individual components of the composite primary endpoint [Time frame: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Time frame: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Time frame: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Time frame: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Time frame: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Time frame: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Time frame: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Time frame: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Time frame: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Time frame: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Time frame: 48 hours after admission to the normal ward]
- Quantitative metrics of mean arterial pressure [Time frame: 48 hours after admission to the normal ward]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Medical Center Hamburg-Eppendorf — Hamburg
Identifiers
NCT: NCT07385092 · 2023-101178-BO-ff