Optimizing blood volume before surgery using echocardiography
Official title: Effect of Preoperative Stroke Volume Optimization Using Transthoracic Echocardiography on Arterial Hypotension Following Induction of Intravenous Anesthesia. A Prospective, Double Blinded Randomized Study.
Run by University Hospital, Caen · NCT06639737 · Data updated 2026-11-12
This study is testing if using ultrasound to check blood volume before surgery can help prevent low blood pressure right after anesthesia in patients who are at higher risk for complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen, Normandy) |
| Status | Recruiting |
| Started | October 4, 2024 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2027 |
| Registry record updated | October 15, 2024 |
| Trial ID | NCT06639737 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older classified as ASA physical status 3 or 4, requiring general anesthesia for intermediate or high-risk surgical procedures.
✕Probably not a fit
Patients who are pregnant, minors, or those with immediate life-threatening emergencies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates whether non-invasive preoperative stroke volume optimization through transthoracic echocardiography can reduce the incidence and severity of arterial hypotension following the induction of general anesthesia. It involves a prospective, randomized, controlled, double-blinded design, where patients classified as ASA 3 or 4 and requiring intermediate or high-risk surgery will be evaluated. The primary objective is to compare the incidence of arterial hypotension within the first 15 minutes post-anesthesia induction. A thorough preoperative assessment will be conducted by an anesthesiologist to determine the best perioperative strategy for each patient.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of arterial hypotension and its associated complications during and after surgery.
How similar studies have gone: Previous studies have shown promising results with similar approaches to optimizing hemodynamics in surgical patients, suggesting potential for success in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Universty Hospital of Caen
Caen, Normandy, France Recruiting
Study contacts
- Study coordinator: jean-luc HANOUZ, MD PhD
- Email: hanouz-jl@chu-caen.fr
- Phone: 02 31 06 47 36
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.