Blood Pressure Determination, Hemodynamic Monitoring, Postoperative Complications
Conditions
Keywords
Volume clamp, Continuous non invasive blood pressure monitoring
Brief summary
Continuous non-invasive arterial pressure monitoring has the potential to decrease the duration of intraoperative hypotension and hypertension compared to conventional intermittent blood pressure monitoring. Chen et al. demonstrated using continuous non-invasive arterial pressure devices for every hour of surgery it is possible to identify an average of 14 minutes of potentially treatable hypotensive and hypertensive time(12). Whether the ability to detect more hypotension events by continuous non-invasive arterial pressure monitoring use can improve patient outcomes, is still an open research question
Interventions
DEVICEContinuous Non Invasive Blood Pressure Monitoring
Continuous non-invasive arterial pressure monitoring
DEVICEIntermittent Non Invasive Blood Pressure Monitoring
Intermittent non-invasive arterial pressure monitoring
Sponsors
University of Messina
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult (age ≥18 years) patients scheduled for elective non-cardiac surgery in participating centers * Surgical case planned with non invasive blood pressure monitoring according to local clinical practice or policies.
Exclusion criteria
* Missing of preoperative serum creatinine during 30 days prior surgery * Preoperative dialysis * Chronic kidney disease (eGFR \< 60ml/min Cockcroft-Gault equation) * Surgical procedure lasting less than 60 min * Planned use of permissive hypotension * Urological procedures (including nephrectomy and renal transplantation) * Refusal to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative myocardial injury | 1 week | The primary outcome will be the proportions of myocardial injury (Definitions: elevation of serum Troponin T (TnT) \>= 30 ng/L in the first post-operative week) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative Acute kidney injury | 1 week | Proportions of postoperative AKI (Definition: increase in postoperative serum creatinine concentration during the first 7 postoperative days by more than 1.5-fold or greater than 0.3 mg/dl. Preoperative concentration was defined as the most recent recorded measurement within 30 days before the surgery) |
| Post operative death | 28 day after surgery | Death during postoperative hospital stay |
| Events 30d post surgery | 30 days after surgery | Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death) |
| Events 90d post surgery | 90 days after surgery | Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death) |
Countries
Italy
Outcome results
None listed