Intraoperative Hypotension
Conditions
Keywords
finger-cuff, blood pressure, intraoperative hypotension
Brief summary
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.
Detailed description
not provided
Interventions
DEVICEContinuous finger-cuff arterial pressure monitoring
Arterial pressure will be monitored using continuous non-invasive finger-cuff arterial pressure monitoring.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We will include three types of patients: 1. Patients scheduled for ambulatory (outpatient) elective non-cardiac surgery expected to last ≥30 minutes 2. Low-risk patients (ASA I+II) having inpatient elective non-cardiac surgery expected to last ≥60 minutes 3. Moderate-risk patients (ASA III) having inpatient elective non-cardiac surgery expected to last ≥60 minutes 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: * Emergency surgery * Patients on renal replacement therapy * Contraindications for finger-cuff monitoring (e.g., Raynaud disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-weighted average mean arterial pressure <65 mmHg | during the start of induction of general anesthesia until the end of surgery |
Secondary
| Measure | 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 |
| 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 |
Countries
Germany
Outcome results
None listed