Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery (COME ON NOW)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vital Sign Monitoring; Non-cardiac Surgery; Anesthesiology; Post Operative Complications; RCT
• Intervention / Treatment: Device: Blinded continuous vital sign monitoring; Device: Unblinded continuous vital sign monitoring

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.

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen K Thomsen, MD; Phone Number: +4940741070215; Email: kr.thomsen@uke.de
• Study Contact Backup: Name: Simon Stemmler, MD; Phone Number: +4940741066077; Email: s.stemmler@uke.de

Study Locations

• Germany
  • Hamburg
    • Hamburg, Hamburg, Germany, 20251
      • Recruiting
      • University Medical Center Hamburg-Eppendorf
      • Contact: Kristen K Thomsen, MD; Phone Number: +4940741070215; Email: kr.thomsen@uke.de
      • Contact: Simon Stemmler, MD; Phone Number: +4940741066077; Email: s.stemmler@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Blinded continuous vital sign monitoring; 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 recorded but not available to patients, clinicians, or investigators.
Experimental: Unblinded 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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: they are documented in the medical record, and; 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.	48 hours after admission to the normal ward

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Bernd Saugel, MD, Universitatsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 13, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: anesthesia; hypotension; vital signs; anesthesiology; post-operative complications; post-operative care; vital sign monitoring; continuous vital signs
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 2023-101178-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No