Elective Endovascular Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours, Elective Open Abdominal Aortic Surgery With an Expected Surgical Duration Exceeding 2 Hours
Conditions
Keywords
hypotension, Hypotension Prediction Index, Acumen IQ, FloTrac, haemodynamic monitoring,, aortic abdominal surgery, major vascular surgery
Brief summary
The standard procedure during general anesthesia is to monitor vital functions, including cardiovascular functions such as cardiac electrical activity, using continuous ECG recording, blood pressure measurement with a sphygmomanometer, heart rate measurement, and tissue oxygenation measurement with a pulse oximeter. These are non-invasive methods, which are often insufficient in the case of extensive procedures within the abdominal aorta. In such cases, the anesthesiologist additionally use direct blood pressure measurements and central venous pressure measurements. To perform these measurements, it is necessary to insert a cannula into an artery (usually the radial artery) and a catheter into the central veins (through the internal jugular or subclavian vein). Vascular cannulation is an invasive method and may be associated with complications such as vascular thrombosis, infection at the puncture site or catheter-related infections, pneumothorax, air embolism, cardiac arrhythmias, neuropathies, hematomas, and bleeding. At the same time, they allow for a more accurate assessment of cardiovascular function and the implementation of appropriate treatment, including the administration of large amounts of infusion fluids, vasoconstrictors, and cardiac support drugs. In the current study, the investigators will additionally use a special sensor and monitor to assess the heart's performance (cardiac output) and its response to the treatment used, optimizing and supporting the circulatory system. This monitoring requires the insertion of a catheter into a central vein and artery, which is necessary during vascular surgery procedures and does not involve any additional invasive procedures. In the postoperative period, the investigators will analyze the frequency of abnormalities in laboratory tests routinely collected after surgery and the function of the central nervous system by performing simple non-invasive cognitive function tests. The benefits of using the method of assessing the patient's response to surgery and anesthesia in presented study are related to increased safety for each patient and improved perioperative treatment for all patients undergoing surgery.
Interventions
DEVICEHPI guided heamodynamic monitoring
The investigators hypothesise that HPI-guided haemodynamic management, when implemented with protocol refinements to mitigate hypertensive overcorrection, will reduce the burden of intraoperative hypotension compared with standard APCO monitoring in patients undergoing major abdominal aortic surgery. Secondary objectives include evaluation of postoperative organ injury, assessment of intraoperative hypertension as a safety outcome, and characterisation of fluid and vasopressor requirements. By testing this hypothesis in a rigorously designed, adequately powered trial, the investigators aim to clarify whether predictive haemodynamic monitoring offers clinically meaningful advantages over current reactive approaches in this high-risk population.
DEVICEStandard Heamodynamic Managament according to APCO Monitoring
Standard Heamodynamic Managament according to APCO Monitoring with MAP target of 75 mmHg
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. American Society of Anesthesiologists (ASA) physical status classification III or IV 3. Scheduled for elective major abdominal aortic surgery (open or endovascular repair) with an expected surgical duration exceeding 2 hours 4. Able to provide written informed consent
Exclusion criteria
1. Emergency or urgent surgery 2. Pregnancy or breastfeeding or positive/uncertain pregnancy test 3. Haemodynamically significant valvular heart disease: * Severe aortic stenosis (aortic valve area \< 1.5 cm\^2) * Moderate to severe aortic regurgitation * Moderate to severe mitral regurgitation * Moderate to severe mitral stenosis 4. Severe heart failure with left ventricular ejection fraction \< 35% 5. Permanent atrial fibrillation (reduces accuracy of pulse contour analysis) 6. Inability to provide informed consent 7. Participation in another interventional trial that may influence haemodynamic management or study outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time-weighted average of mean arterial pressure below 65 mmHg (TWA-MAP < 65 mmHg) | From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days | The primary outcome is the time-weighted average of mean arterial pressure below 65 mmHg (TWA-MAP \< 65 mmHg) during the period from induction of anaesthesia to departure from the operating theatre. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative hypertension | From the beginning of the anesthesia to the end of anesthesia (from induction - start of anesthesia to end of anesthesia - discharge from the post anesthesia department), assessed up to 30 days | * Total time with MAP \> 90 mmHg (minutes and % of monitoring time) * Total time with MAP \> 100 mmHg (minutes and % of monitoring time) * TWA-MAP \> 90 mmHg and TWA-MAP \> 100 mmHg |
| All-cause mortality at 90 days | postoperative 90 days | All-cause mortality at 90 days |
| Composite postoperative organ complications within 7 days | 7 postoperative days | Composite endpoint: at least one of the following within 7 days after surgery. * Acute kidney injury (AKI) per KDIGO criteria. * Myocardial injury after non-cardiac surgery (MINS): troponin ≥ assay-specific 99th-percentile upper reference limit. * Stroke: new focal neurological deficit confirmed by neuroimaging. * Postoperative respiratory failure (within 7 days or before ICU discharge): failure to extubate within 48 h; unplanned reintubation for respiratory failure; or unplanned non-invasive ventilation / high-flow nasal oxygen ≥ 6 h after extubation. * Postoperative circulatory failure (within 48 h): norepinephrine ≥ 0.1 µg/kg/min for ≥ 6 h despite adequate fluid resuscitation; initiation/escalation of inotropes for tissue hypoperfusion; or mechanical circulatory support (IABP, ECMO, or equivalent). Full operational definitions are provided in the study protocol. |
Countries
Poland
Contacts
CONTACTJakub Szrama, PhD
CONTACTMariusz Gezela
STUDY_CHAIRPaweł Sobczyński, Professor
Department of Anesthesiology and Intensive Therapy, Poznan University of Medical Sciences
Outcome results
None listed