Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery
NCT07385092 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264
Last updated 2026-03-02
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.
Conditions
- Vital Sign Monitoring
- Post Operative Complications
- Non-cardiac Surgery
- RCT
- Anesthesiology
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 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.
- DEVICE
-
Blinded continuous vital sign monitoring
Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
Sponsors & Collaborators
-
Universitätsklinikum Hamburg-Eppendorf
lead OTHER
Principal Investigators
-
Bernd Saugel, MD · Universitätsklinikum Hamburg-Eppendorf
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-24
- Primary Completion
- 2026-11-01
- Completion
- 2026-12-31
Countries
- Germany
Study Locations
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