Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure

Study Overview
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Brief Summary
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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

Official Title
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Continuous Vs Intermittent Non Invasive Blood Pressure Monitoring in Preventing Post Operative Organ Failure

Conditions
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Blood Pressure Determination, Hemodynamic Monitoring, Postoperative Complications

Intervention / Treatment
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* Device: Continuous Non Invasive Blood Pressure Monitoring
* Device: Intermittent Non Invasive Blood Pressure Monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cNIBP<br>Continuous non invasive blood pressure monitor (Volume clamp) | Device: Continuous Non Invasive Blood Pressure Monitoring<br>* Continuous non-invasive arterial pressure monitoring<br>|
| Active Comparator: iNIBP<br>Intermittent Non Invasive Blood Pressure (Brachial Cuff) | Device: Intermittent Non Invasive Blood Pressure Monitoring<br>* Intermittent non-invasive arterial pressure monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative myocardial injury | 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) | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative Acute kidney injury | 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) | 1 week | 
| Post operative death | Death during postoperative hospital stay | 28 day after surgery | 
| Events 30d post surgery | Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death) | 30 days after surgery | 
| Events 90d post surgery | Any of the following events after surgery: Stroke, Non fatal cardiac arrest, AKI stage 2-3, Sepsis, Death) | 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volume clamp, Continuous non invasive blood pressure monitoring