Using ultrasound and fluid therapy to prevent low blood pressure after spinal anesthesia in elderly patients with heart conditions
Point of Care Ultrasound and Fluids Co-loading for the Prevention of Spinal-induced Hypotension in Dehydrated Elderly Patients and Cardiac Diseases
This study is testing if using ultrasound and giving fluids can help older patients with heart problems avoid low blood pressure after receiving spinal anesthesia for hip surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 70 Years to 100 Years |
| Sex | All |
| Sponsor | Attikon Hospital Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT06206434 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on elderly patients over 70 years old with cardiac diseases who are undergoing orthopedic surgery for proximal femur fractures under spinal anesthesia. The study aims to evaluate the effectiveness of point of care ultrasound (POCUS) and fluid co-loading in reducing the incidence of spinal-induced hypotension. Patients are screened based on specific cardiovascular criteria and undergo various preoperative assessments, including echocardiography, to ensure they meet the eligibility requirements. The study will monitor hemodynamic stability and postoperative outcomes to determine the impact of the interventions.
Who should consider this trial
Good fit: Ideal candidates are elderly patients over 70 years old with a specific dIVCmax-to-IVCCI ratio and compensated cardiac disease.
Not a fit: Patients with severe cardiac conditions, significant valve regurgitation, or those experiencing intraoperative hypotension due to bleeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of postoperative complications related to hypotension in vulnerable elderly patients.
How similar studies have performed: While the use of POCUS in similar contexts has shown promise, this specific approach combining fluid co-loading and ultrasound in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All the included patients have BUN-to-creatinne ratio\>20 * LV-EF between 35% and 50% * Normal RV function indices \[tricuspid annular plane systolic excursion (TAPSE) index \> 16 and tricuspid annular systolic velocity (TASV) \> 10 cm/sec and fractional area change (FAC) \> 35%)\] Exclusion Criteria: * Poor acoustic windows, * Tthose who were included during the initial screening, but they finally found with pulmonary hypertension (peak tricuspid velocity \> 3.4 m/sec), tricuspid/mitral/pulmonary valve regurgitation grade 3 or 4, severe aortic/mitral valve stenosis, and severe mitral annulus calcification on the preoperative echocardiogram. * All patients with maximum cephalad dermatomal extension of the spinal sensory block below T12 or arterial hypotension related to overt intraoperative bleeding (\>150 cc) are excluded. * Intraoperrative hypotension due to bleeding and cement placement
Where this trial is running
Athens
- Theodosios Saranteas — Athens, Greece (Recruiting)
Study contacts
- Principal investigator: Theodosios Saranteas, MD, PhD — University of Athens
- Study coordinator: Theodosios Saranteas, MD, PhD
- Email: thsaranteas@gmail.com
- Phone: 00306973928195
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.