CompletedNot Applicable

Echocardiography and Spinal Induced Hypotension.

Greece61 participantsStarted 2019-08-01

Plain-language summary

Modern guidelines have combined both the maximum diameter of IVC at expiration (dIVC max) and the IVCCI to appreciate right atrial pressure (RAP) measurements and consequently to assess intravascular volume status. In fact, IVC diameter \<2.1 cm with IVCCI \>20% (quite inspiration) suggests normal RAP of 3mmHg (range, 0-5mmHg), whereas IVC diameter \>2.1 cm with IVCCI\<20% suggests high RAP of 15mmHg (range, 10-20mmHg). In occasions where the IVC diameter and collapse is not fit the above categories, an intermediate value of 8 mmHg (range, 5-10 mmHg) is applied. From a clinical standpoint, it is conceivable that both measurements must be measured in isolation to enable RAP assessment. To circumvent this limitation the two indices have been consolidated to dIVCmax-to-IVCCI ratio. Although this ratio has been shown high accuracy to predict spinal-induced hypotension in elderly patients with preserved ejection fraction (EF) of the left ventricle (LV), its value in patients with cardiac dysfunction and reduced LV-EF has not been investigated. From the aforementioned, this study sets out to address the role of dIVCmax-to-IVCCI ratio in the prediction as well as in the management of hypotension after spinal anesthesia in elderly orthopaedic patients with reduced LV-EF.

Who can participate

Age range

70 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Orthopaedic trauma patients Reduced LV-EF (35% \<EF\<50%) Elderly patients Exclusion Criteria: * Patients with right ventricle (RV) dysfunction/patients with LV-EF\<35%/ * Severe pulmonary hypertension * Tachycardia (heart rate \> 100 beats/min), atrial fibrillation. * Patients with tricuspid and mitral regurgitation more than grade 2 and those with more than moderate valvular stenosis were excluded. * Left ventricular dysynchrony * TAPSE index\<16 and/orTDI-tricuspid annulus\<10 cm/sec and/or Fractional Area Shortening\<35. Spinal block below T-12 level Overt intraoperative haemorhage

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Predictive value of dIVCmax-to-IVCCI ratio

Timeframe: 18 months

Trial details

NCT IDNCT04001881

SponsorAttikon Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-04-25

View on ClinicalTrials.gov More Spinal Anesthetic Toxicity trials