Improving blood pressure monitoring during spinal anesthesia in elderly patients with femur fractures
Continuous Non-Invasive Blood Pressure Monitoring Versus Intermittent During Spinal Anesthesia in Elderly Patients With Femoral Fracture: Observational Cohort Study
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06396884
This study is testing if using continuous non-invasive blood pressure monitoring during surgery for hip fractures in older patients can help them recover faster and avoid complications compared to traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 146 (estimated) |
| Ages | 65 Years to 99 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Roma) |
| Trial ID | NCT06396884 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on elderly patients over 65 years old who are undergoing surgery for proximal femur fractures using subarachnoid anesthesia. It aims to compare the effectiveness of continuous non-invasive blood pressure monitoring with traditional oscillometric methods in reducing hospitalization duration and post-operative complications. The study will assess how well these monitoring techniques can detect hypotension, which is a common side effect of spinal anesthesia, and their impact on patient outcomes. By utilizing advanced hemodynamic parameters, the study seeks to enhance the safety and efficacy of anesthesia in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 65 years old with ASA physical status I-III who are scheduled for surgical intervention for femoral fractures under spinal anesthesia.
Not a fit: Patients with severe valvular heart disease, heart failure, vascular system pathologies, or those with contraindications to spinal anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring techniques that reduce complications and hospital stays for elderly patients undergoing surgery.
How similar studies have performed: Other studies have shown promising results with continuous non-invasive blood pressure monitoring, suggesting potential benefits in similar clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma
- Rossano Festa — Roma, Italy (RECRUITING)
Study contacts
- Principal investigator: ROSSANO RF FESTA, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: ROSSANO RF FESTA, MD
- Email: rossano.festa@policlinicogemelli.it
- Phone: +390630154507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non Invasive Hemodynamic Monitoring, Proximal Femur Fracture, Fluid Therapy