RecruitingNot ApplicableNCT07385092

Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery

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


Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrollment

264 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 45 Years

Inclusion Criteria1

  • 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 Criteria5

  • 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

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Interventions

DEVICEUnblinded 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.

DEVICEBlinded continuous vital sign monitoring

Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.


Locations(1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, Germany

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