Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Emergency surgery
Pregnancy
Impossibility to perform continuous monitoring with the Radius VSM sensor (Masimo, Irvine, CA)
Atrial fibrillation
Trial design
Design model
Parallel
Treatments tested in this trial
Unblinded continuous vital sign monitoring
DeviceContinuous 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
DeviceContinuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
Treatment groups
264 Participants
are divided into 2 treatment groupsGroup A: Blinded continuous vital sign monitoringSham comparator 1 intervention
Group B: Unblinded continuous vital sign monitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
48 hours after admission to the normal wardSecondary outcomes
1
Individual components of the composite primary endpoint
Total duration of a SpO2 \<85% per hour (minutes per hour)
Time frame
48 hours after admission to the normal ward2
Individual components of the composite primary endpoint
Total duration of a MAP \<60 mmHg per hour (minutes per hour)
Time frame
48 hours after admission to the normal ward3
Individual components of the composite primary endpoint
Total duration of a heart rate \<45 bpm per hour (minutes per hour)
Time frame
48 hours after admission to the normal ward4
Individual components of the composite primary endpoint
Total duration of a heart rate \>130 bpm per hour (minutes per hour)
Time frame
48 hours after admission to the normal wardOther outcomes
1
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.
Time frame
48 hours after admission to the normal ward2
Time-to-event endpoint
Time-to-event endpoint with the event "hospital discharge" within 30 days after surgery.
Time frame
30 days after index surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov