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Preoperative Blood Volume Optimization Using Transthoracic Echocardiography

RecruitingNAAges 18 Years - 99 YearsAllUniversity Hospital, Caen
NCT06639737 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Immediately following the induction of general anesthesia, arterial hypotension may occur with an incidence of about 40% in patients classified as ASA 3 or 4. Perioperative arterial hypotension is associated with increased perioperative morbidity and mortality. The increased mortality associated with perioperative arterial hypotension has been reported up to 30 and 90 days after surgery. This association appears to be both dose-dependent and time-dependent (severity and duration of arterial hypotension). EchOptimal study aims to determine whether non invasive preoperative stroke volume optimization using transthoracic echocardiography (TTE) can reduce the incidence and severity arterial hypotension following induction of general anesthesia. This is prospective, randomized, controlled, double blinded study approved by ethics comittee. The primary objective of this study is to compare t

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient aged 18 years or older, * Affiliated with social security, * Informed about the study and having signed the informed consent form, * Requires surgical intervention under general anesthesia, * Intermediate or high risk of cardiovascular events within 30 days, * ASA phyiscal status Classification 3 or 4 Exclusion Criteria: \- Pregnant or breastfeeding women, * Patients under guardianship, curatorship, judicial protection, or legal protection, * Minors, * Patients with contraindications to intravenous induction with Propofol and Remifentanil, * Patients not fasting at the time of surgery, * Patients with an immediate life-threatening emergency or requiring surgery without delay to ensure survival, * Patients with contraindications for placing an arterial pressure catheter in the radial artery: bilateral negative Allen's test indicating absence of ulnar collateral circulation, Raynaud's syndrome, Buerger's disease, severe dyslipidemias, * Patients with characteristics making the measurement of ITVSAo uninterpretable: atrial fibrillation, non-sinus electrocardiogram, severe valvulopathy, documented right or left heart failure, * Patients under general anesthesia before arrival in the operating room, * Patients receiving aminergic support before anesthetic induction, * Patients requiring rapid sequence induction, * Patients treated with ACE inhibitors/ARBs who have not discontinued the treatment on the day of the procedure
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What it tests

  • preoperative stroke volume optimization
  • Post induction stroke volume optimization
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Where

1 site
Universty Hospital of Caen
Caen, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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