Bone Cement Implantation Syndrome, Hip Arthroplasty, Perioperative Hemodynamic Optimization
Conditions
Keywords
Hemodynamic Monitoring, Pressure Recording Analytical Method, Cardiac Output, Neuraxial Anesthesia Cemented, Hip Arthroplasty, Non-Cemented Hip Arthroplasty, Bone Cement Implantation Syndrome, Arterial Waveform Analysis, Perioperative Anesthesia
Brief summary
Hip arthroplasty is a commonly performed surgical procedure in elderly patients, particularly following proximal femoral fractures. During these operations, significant and sudden changes in blood pressure and heart function may occur, especially during bone cement implantation. These hemodynamic alterations may lead to decreased organ perfusion and potential cardiac or renal complications. Traditional non-invasive monitoring methods may not adequately detect rapid perioperative cardiovascular changes. Advanced arterial waveform analysis allows continuous assessment of cardiac output and other hemodynamic parameters in real time. This observational study aims to evaluate perioperative hemodynamic changes in patients undergoing hip arthroplasty under neuraxial anesthesia, comparing cemented and non-cemented procedures. Hemodynamic parameters will be assessed using a pressure recording analytical method through invasive arterial monitoring. In addition, the study investigates the association between intraoperative hemodynamic changes and early postoperative cardiac and renal biomarkers. The findings may contribute to improved perioperative monitoring strategies and safer anesthetic management in high-risk orthopedic surgery patients.
Detailed description
Perioperative hemodynamic monitoring is a cornerstone of anesthetic management, enabling the assessment of cardiovascular function and optimization of organ perfusion. Hip arthroplasty is frequently performed in elderly patients and is associated with a risk of significant hemodynamic instability, particularly during bone cement implantation. Bone Cement Implantation Syndrome is characterized by hypotension, hypoxia, and cardiovascular collapse, which may result in postoperative organ dysfunction. In this prospective observational study, patients undergoing hip arthroplasty under neuraxial anesthesia are evaluated to characterize perioperative hemodynamic changes using continuous arterial waveform analysis. A pressure recording analytical method is used to measure cardiac output and related hemodynamic parameters through invasive arterial blood pressure monitoring. Patients aged 50 to 90 years with ASA physical status I-III scheduled for elective or fracture-related hip arthroplasty are included. Eligible patients are divided into two groups according to surgical technique: cemented and non-cemented hip arthroplasty. No intervention or randomization is performed; surgical and anesthetic management follow routine clinical practice. Hemodynamic parameters are recorded at predefined time points, including baseline measurements, after neuraxial anesthesia, at surgical incision, before and after cement or prosthesis implantation, during the first hypotensive episode if present, and at the end of surgery. Fluid responsiveness is assessed using Trendelenburg maneuver-induced changes in cardiac output and stroke volume. Arterial blood gas analysis is performed intraoperatively as clinically indicated and routinely at the end of surgery. Postoperative laboratory assessments include serum creatinine, NT-proBNP, and troponin I measured on postoperative day 0, followed by daily measurements on postoperative days 1, 2, and 3. Urine output is monitored during the postoperative period. The primary objective of the study is to evaluate perioperative hemodynamic changes associated with bone cement implantation. Secondary objectives include assessing the relationship between intraoperative hemodynamic alterations and early postoperative cardiac and renal biomarkers. All collected data are analyzed statistically to determine differences between cemented and non-cemented procedures and to explore potential predictors of organ dysfunction.
Interventions
OTHERNo intervention (observational study)
This is an observational study. No experimental intervention is assigned. All surgical and anesthetic procedures, including arterial monitoring, are performed as part of standard clinical care.
Sponsors
Ataturk University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age between 50 and 90 years * Scheduled for hip arthroplasty under neuraxial anesthesia * ASA physical status I-III * Body mass index (BMI) \<30 kg/m² * Planned invasive arterial blood pressure monitoring * Expected surgical duration \>2 hours * Ability to provide written informed consent
Exclusion criteria
* Refusal to participate or inability to provide informed consent * Planned surgery without invasive arterial blood pressure monitoring * Mean arterial pressure \<65 mmHg at initial monitoring * Use of vasopressors or inotropes before anesthesia * Fluid responsiveness detected by Trendelenburg maneuver * Intraoperative blood loss exceeding tolerable limits * Additional epidural drug administration during cement implantation * Estimated glomerular filtration rate \<30 mL/min/1.73 m² * Ongoing renal replacement therapy * Preoperative intensive care unit requirement * NYHA class III-IV heart failure or left ventricular ejection fraction \<40% * Severe valvular heart disease * Persistent cardiac arrhythmia * Coagulation disorders * Sensory block level below T8 after initial neuraxial anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Change in Cardiac Output Assessed by Arterial Waveform Analysis | From immediately before neuraxial anesthesia through the end of surgery, assessed at predefined perioperative time points, up to 4 hours per participant. | Cardiac output (L/min) is assessed using arterial waveform analysis derived from invasive arterial blood pressure monitoring. Cardiac output values are recorded at predefined perioperative time points: immediately before neuraxial anesthesia (baseline), after neuraxial anesthesia, at surgical incision, immediately before cement or prosthesis implantation, immediately after cement or prosthesis implantation, at the first hypotensive episode if present, and at the end of surgery. The primary outcome is the change in cardiac output across these predefined perioperative time points. Changes over time will be compared between the cemented and non-cemented hip arthroplasty groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intraoperative Hypotension After Cement/Prosthesis Implantation | From cement/prosthesis implantation until 5 minutes after implantation (intraoperative) | Incidence of hypotension defined as MAP \<65 mmHg occurring after cement or prosthesis implantation. The first hypotensive episode is recorded; if hypotension does not occur, hemodynamic values at 5 minutes after implantation are used for comparison between groups. |
| Perioperative Mean Arterial Pressure Changes | From baseline measurement to end of surgery (intraoperative) | MAP values recorded at predefined intraoperative time points (baseline, after neuraxial anesthesia, incision, pre-implantation, post-implantation/first hypotension or 5th minute, end of surgery) and compared between cemented and non-cemented groups. |
| Perioperative Stroke Volume Changes | From baseline measurement to end of surgery (intraoperative) | Stroke volume values measured by arterial waveform analysis and recorded at predefined intraoperative time points (baseline, after neuraxial anesthesia, incision, pre-implantation, post-implantation/first hypotension or 5th minute, end of surgery). Group comparisons are performed. |
| Cardiac Power Output Changes During Surgery | From baseline measurement to end of surgery (intraoperative) | Cardiac power output values derived from arterial waveform analysis are recorded at predefined intraoperative time points and compared between cemented and non-cemented hip arthroplasty groups. |
| Cardiac Power Index Changes During Surgery | From baseline measurement to end of surgery (intraoperative) | Cardiac power index values derived from arterial waveform analysis are recorded at predefined intraoperative time points and compared between cemented and non-cemented hip arthroplasty groups. |
| Fluid Responsiveness Assessed by Trendelenburg Maneuver | Pre-anesthesia period (after arterial line placement, before neuraxial anesthesia) | Changes in cardiac output and stroke volume in response to Trendelenburg maneuver are recorded to assess fluid responsiveness prior to neuraxial anesthesia, using arterial waveform analysis. |
| Postoperative Troponin I Levels | Postoperative day 0 to postoperative day 3 | Troponin I levels measured from arterial blood samples postoperatively on day 0 and daily on postoperative days 1, 2, and 3. Values are compared between groups and evaluated in relation to intraoperative hemodynamic changes. |
| Postoperative NT-proBNP Levels | Postoperative day 0 to postoperative day 3 | NT-proBNP levels measured from arterial blood samples postoperatively on day 0 and daily on postoperative days 1, 2, and 3. Values are compared between groups and evaluated in relation to intraoperative hemodynamic changes. |
| Postoperative Serum Creatinine Levels | Postoperative day 0 to postoperative day 3 | Serum creatinine measured postoperatively on day 0 and daily on postoperative days 1, 2, and 3. Group comparisons are performed and associations with intraoperative hemodynamic changes are explored. |
| Postoperative Urine Output | Postoperative day 1 to postoperative day 3 | Urine output recorded on postoperative days 1, 2, and 3 as an indicator of renal function, compared between cemented and non-cemented groups and evaluated in relation to intraoperative hemodynamic changes. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMuhammed Enes Aydın, Principal Investigator
Ataturk University Department of Anesthesiology and Reanimation
Outcome results
None listed