Clinical trial NCT06396884: Hemodynamic Optimization During Spinal Anesthesia in the Elderly
Official title: Continuous Non-Invasive Blood Pressure Monitoring Versus Intermittent During Spinal Anesthesia in Elderly Patients With Femoral Fracture: Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Invasive Hemodynamic Monitoring
Proximal Femur Fracture
Fluid Therapy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 146
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study aims to enroll 146 patients aged over 65 years, with ASA (American Society of Anesthesiologists) scores I-III, undergoing surgery for femoral fracture under spinal anesthesia. After obtaining informed consent, 73 patients from a prospectively enrolled cohort (ClearSight group) will be compared with 73 patients from a retrospective cohort (Control Group) who underwent the same type of surgery under spinal anesthesia between May 2023 and December 2023 and were included based on the same eligibility criteria.

Brief summary: In elderly patients over 65 years of age, proximal femur fracture is the most common type of fracture, and surgical intervention is typically required for the majority of cases. Subarachnoid anesthesia is commonly used for this type of surgery. The objective of this study is to assess the efficacy of continuous non-invasive blood pressure and hemodynamic monitoring compared to traditional methods of blood pressure measurement in reducing the duration of hospitalization and the incidence of post-operative complications in elderly patients undergoing surgery for femur fracture under subarachnoid anesthesia.

Detailed description: The proximal femoral fracture is the most frequent fracture in elderly patients over 65 years old, often affected by multiple comorbidities. It is one of the main causes of hospitalization in this population and is associated with high mortality rates.

Surgical treatment is indicated for the majority of fractures, and spinal anesthesia is the most commonly used technique for this type of surgery.

Hypotension is a very common side effect after spinal anesthesia, with a reported incidence of 16%-33%, attributable to a reduction in systemic vascular resistance, cardiac output, or both mechanisms. Several studies have demonstrated the association between intraoperative hypotension, usually defined as a mean arterial pressure \<65 mmHg, myocardial and renal organ damage, and 30-day mortality.

In clinical practice oscillometric, non-invasive blood pressure measurement (NIBP) is the first choice of blood pressure monitoring in the majority of low and moderate risk surgeries. This monitoring system is a non-invasive cuff around the upper arm (NIBP-arm), which allows for non-invasive detection of blood pressure values, usually every 5 minutes.

New continuous noninvasive devices to acquire instantaneous arterial blood pressure (ClearSight™, Edwards) may be more sensitive to detect procedural hypotension. Additionally, this system provides advanced hemodynamic parameters not available with traditional oscillometric methods of blood pressure measurement, supporting the anesthesiologist in proactive hemodynamic management of the patient.

Several systematic reviews have demonstrated the effectiveness of hemodynamic optimization protocols in reducing postoperative complications. Orthopedic surgical procedures, along with abdominal and neurosurgical procedures, are among those that benefit most from the adoption of an advanced hemodynamic monitoring system associated with a Goal-Directed Therapy (GDT) protocol.

One hundred forty-six patients, aged ≥ 65 years, with an American Society of Anaesthesiologists' (ASA) score I-III, undergoing surgical intervention due to femoral fracture and spinal anaesthesia will be enrolled. Seventy-three patients from a prospectively enrolled cohort (ClearSight group) will be compared with seventy-three patients from a retrospective cohort (Control Group) who underwent the same type of surgery under spinal anesthesia between May 2023 and December 2023 and were included according to the same eligibility criteria.

In the retrospectively enrolled patient cohort (control group), an intermittent non-invasive blood pressure monitoring system was used, and intraoperative hemodynamic anesthetic management was not standardized but left to the discretion of the attending anesthesiologist, consistently with the protocols of the operating unit.

In the prospectively enrolled patient cohort (Clearsight group), continuous non-invasive monitoring of arterial pressure will be conducted using the ClearSight system, allowing clinicians to implement Goal-Directed Fluid Therapy.

The purpose of this study is to evaluate the effectiveness of continuous non-invasive blood pressure and hemodynamic monitoring compared to traditional methods of blood pressure detection in reducing length of hospital stay and the percentage of post-operative complications in elderly patients undergoing surgery for femoral fracture under spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

Patients with American Society of Anesthesiologists (ASA) physical status I-III, candidate for surgical intervention for femoral fracture under spinal anesthesia.

Exclusion Criteria:

* Severe valvular heart disease
* Heart failure (New York Heart Association - NYHA class ≥ 3)
* Vascular system pathologies
* Allergy or hypersensitivity to local anesthetics
* Absolute contraindications to spinal anesthesia
* Patient refusal to participate to the study

Primary outcomes:
measure: Duration of hospitalization
timeFrame: 10-15 days
Secondary outcomes:
measure: Incidence of at least one postoperative complication
timeFrame: 10-15 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Rossano Festa
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: ROSSANO RF FESTA, MD
role: PRINCIPAL_INVESTIGATOR
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