Anesthesiology, Non-cardiac Surgery, Post Operative Complications, RCT, Vital Sign Monitoring
Conditions
Keywords
continuous vital signs, vital signs, vital sign monitoring, post-operative care, anesthesiology, anesthesia, hypotension, post-operative complications
Brief summary
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
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.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total duration of abnormal vital signs | 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
| Measure | Time frame | Description |
|---|---|---|
| Individual components of the composite primary endpoint | 48 hours after admission to the normal ward | Total duration of a SpO2 \<85% per hour (minutes per hour) |
| Quantitative metrics of peripheral oxygen saturation | 48 hours after admission to the normal ward | Area under a SpO2 of 85% (SpO2 \<85% x min) |
| Quantitative metrics of mean arterial pressure | 48 hours after admission to the normal ward | Area under a MAP of 60 mmHg (mmHg x min) |
| Quantitative metrics of heart rate | 48 hours after admission to the normal ward | Area under a heart rate of 45 bpm (\<45 bpm x min) |
| Quantitative metrics of respiratory rate | 48 hours after admission to the normal ward | Area under a respiratory rate 7/min (\<7/min x min) |
| The incidence of a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, bradycardia, and hypotension. | 48 hours after admission to the normal ward | 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. |
Countries
Germany
Contacts
CONTACTKristen K Thomsen, MD
CONTACTSimon Stemmler, MD
PRINCIPAL_INVESTIGATORBernd Saugel, MD
Universitätsklinikum Hamburg-Eppendorf
Outcome results
None listed