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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Total duration of abnormal vital signs
研究概览
简要总结
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.
详细描述
"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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients ≥45 years scheduled for elective abdominal surgery with planned postoperative admission to a normal ward after an overnight stay in an advanced post-anesthesia care unit.
排除标准
- •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
研究组 & 干预措施
Blinded continuous vital sign monitoring
Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
干预措施: Blinded continuous vital sign monitoring (Device)
Unblinded continuous vital sign monitoring
Continuous ward monitoring with vital signs available to investigators.
干预措施: Unblinded continuous vital sign monitoring (Device)
结局指标
主要结局
Total duration of abnormal vital signs
时间窗: 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.
次要结局
- Individual components of the composite primary endpoint(48 hours after admission to the normal ward)
- Quantitative metrics of peripheral oxygen saturation(48 hours after admission to the normal ward)
- Quantitative metrics of mean arterial pressure(48 hours after admission to the normal ward)
- Quantitative metrics of heart rate(48 hours after admission to the normal ward)
- Quantitative metrics of respiratory rate(48 hours after admission to the normal ward)
- The incidence of a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, bradycardia, and hypotension.(48 hours after admission to the normal ward)
研究者
Kristen Thomsen
MD
Universitätsklinikum Hamburg-Eppendorf