Actively Recruiting

Age: 70Years - 100Years
All Genders
ID06206434

Point of Care Ultrasound and Fluids Co-loading for the Prevention of Spinal-induced Hypotension in Dehydrated Elderly Patients and Cardiac Diseases

Led by Attikon Hospital · Updated on 2025-11-19

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the use of point of care ultrasound (POCUS) and fluid co-loading to prevent spinal-induced hypotension in elderly patients with cardiac diseases undergoing surgery for proximal femur fractures. It focuses on patients over 70 years old who have cardiac conditions that reduce cardiovascular reserve, increasing their risk of hemodynamic instability after spinal anesthesia. Researchers aim to understand if fluid co-loading immediately after spinal anesthesia can reduce episodes of low blood pressure in these dehydrated patients. Participants receive transthoracic echocardiography (TTE) before spinal anesthesia to assess heart function and the inferior vena cava (IVC) characteristics. After spinal anesthesia with ropivacaine, patients are given continuous intravenous infusion of Lactate Ringer's solution. Ultrasound-guided nerve blocks are used before anesthesia to manage pain. Blood pressure and heart function are monitored closely during and after surgery, with hypotension treated according to clinical judgment. Throughout the study, patients undergo detailed heart imaging and monitoring, including ECG, echocardiography scans, and blood pressure measurements. Researchers measure the number of hypotension events after spinal anesthesia, guided by echocardiography, and assess patients' recovery in the post-anesthesia care unit. The study tracks heart performance indices and fluid status, aiming to improve management of spinal-induced hypotension in this vulnerable group.

CONDITIONS

Brief Title

Point of Care Ultrasound and Co-loading in Patients With Spinal-induced Hypotension and Cardiac Diseases

Who Can Participate

Age: 70Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with blood urea nitrogen to creatinine ratio greater than 20
  • Left ventricular ejection fraction between 35% and 50%
  • Normal right ventricle function indices: TAPSE index greater than 16, TASV greater than 10 cm/sec, and fractional area change greater than 35%
Not Eligible

You will not qualify if you...

  • Poor acoustic windows preventing ultrasound assessment
  • Pulmonary hypertension with peak tricuspid velocity over 3.4 m/sec
  • Moderate to severe or severe valve regurgitation or stenosis
  • Severe mitral annulus calcification on preoperative echocardiogram
  • Spinal sensory block with maximum cephalad dermatomal extension below T12
  • Arterial hypotension due to significant intraoperative bleeding over 150 cc
  • Hypotension related to cement placement during surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during preoperative assessment including medical history, physical examination, ECG, X-ray, and specific cardiology exams as needed

Diagnostic Evaluation

Duration - Day of surgery before spinal anesthesia

Participants undergo transthoracic echocardiographic examination before spinal anesthesia to assess cardiac function and guide fluid co-loading.

1 visit (in-person) including echocardiographic assessment immediately prior to spinal anesthesia

Monitoring

Duration - From spinal anesthesia induction until discharge from post-anesthesia care unit (PACU)

Participants are monitored intraoperatively and postoperatively for blood pressure and hemodynamic stability, with fluid co-loading guided by ultrasound findings.

Continuous monitoring during surgery and PACU stay

Trial Site Locations

Total: 1 location

1

Theodosios Saranteas

Athens, Greece

Actively Recruiting

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Research Team

T

Theodosios Saranteas, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Point of care transthoracic echocardiography for the prediction of post - spinal anesthesia hypotension in elderly patients with cardiac diseases and left ventricular dysfunction : Inferior vena cava and post-spinal anesthesia hypotension in elderly patients.

Nefeli Moschovaki, Theodosios Saranteas, Elen Spiliotaki...

https://pubmed.ncbi.nlm.nih.gov/36805418