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This is a randomized trial (1) investigating whether continuous finger-cuff - compared to intermittent oscillometric - arterial pressure monitoring reduces the amount of intraoperative hypotension (specifically, from the start of induction of general anesthesia until the end of surgery) in low-to-moderate risk patients having elective non-cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent oscillometric arterial pressure monitoring | No Intervention | In patients assigned to intermittent oscillometric arterial pressure monitoring, oscillometric arterial pressure measurements will be displayed on the patient monitor and the treating anesthesiologist will be blinded to continuous finger-cuff arterial pressure monitoring. Oscillometric arterial pressure monitoring will be performed in 2.5 minutes intervals, but clinicians are free to perform additional measurements at any time. | |
| Continuous finger-cuff arterial pressure monitoring | Experimental | In patients assigned to continuous finger-cuff arterial pressure monitoring, arterial pressure waveforms and measurements from the finger-cuff will be displayed on the patient monitor and treating anesthesiologists will be blinded to intermittent oscillometric arterial pressure monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous finger-cuff arterial pressure monitoring | Device | Arterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted average mean arterial pressure <65 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted average mean arterial pressure <60 mmHg | during the start of induction of general anesthesia until the end of surgery | |
| Time-weighted average mean arterial pressure <50 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury | Acute kidney injury (binary outcome) will be defined as an increase in postoperative serum creatinine from baseline of at least 0.3 mg/dl or ≥50%. | Up until the first postoperative day |
| Acute myocardial injury |
We will include three types of patients:
We will only include patients who are 18 years or older; who will have general anesthesia; and in whom intermittent arterial pressure monitoring with upper-arm cuff oscillometry is planned.
Patients that meet one or more of the following exclusion criteria cannot participate in the trial:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany |
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| Time-weighted average mean arterial pressure <40 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <65 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <60 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <50 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Absolute number of patients with at least one 1-minute episode of a mean arterial pressure <40 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Cumulative duration of a mean arterial pressure <65 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Time-weighted average mean arterial pressure >100 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Time-weighted average mean arterial pressure >110 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Time-weighted average mean arterial pressure >120 mmHg | during the start of induction of general anesthesia until the end of surgery |
| Time-weighted average mean arterial pressure >140 mmHg | during the start of induction of general anesthesia until the end of surgery |
Acute myocardial injury (binary outcome) will be defined based on the definition of "myocardial injury and infarction associated with non-cardiac procedures" according to the Fourth Universal Definition of Myocardial Infarction (2018)
| Up until the first postoperative day |
| Time-weighted average of the percentage decrease in regional cerebral oxygen saturation from the baseline | during the start of induction of general anesthesia until the end of surgery |
| Incidence of cerebral hypoxia | Cerebral hypoxia will be defined as a regional cerebral oxygen saturation (rcSO2) <50% or a decrease in rcSO2 >20% from baseline (if the baseline was ≥50%) or a decrease in rcSO2 >15% from baseline (if the baseline was <50%). | during the start of induction of general anesthesia until the end of surgery |
| Cumulative duration of cerebral hypoxia | Cerebral hypoxia will be defined as a regional cerebral oxygen saturation (rcSO2) <50% or a decrease in rcSO2 >20% from baseline (if the baseline was ≥50%) or a decrease in rcSO2 >15% from baseline (if the baseline was <50%). | during the start of induction of general anesthesia until the end of surgery |