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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Study 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

Primary outcome measure(s)

• 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.

Trial sites (1)

More Universitätsklinikum Hamburg-Eppendorf trials in Germany