NCT06639737Recruiting
Preoperative Blood Volume Optimization Using Transthoracic Echocardiography
Effect of Preoperative Stroke Volume Optimization Using Transthoracic Echocardiography on Arterial Hypotension Following Induction of Intravenous Anesthesia. A Prospective, Double Blinded Randomized Study.
Source: ClinicalTrials.gov · Last updated 15 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 the incidence of arterial hypotension (mean arterial pressure \< 65 mmHg) within the first 15 minutes following the induction of general anesthesia, between 2 groups : * standard current care (stroke volume optimized after induction of general anesthesia using oesophageal doppler) and * preopertaive stroke volume optimization using transthoracic echocardiography measument of subaortic velocity time integral.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 10 Oct 2024
- Start date
- 4 Oct 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- University Hospital, Caen
- Diseases
- Stroke
- NCT number
- NCT06639737
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 4 Oct 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients not fasting at the time of surgery,
- Patients with an immediate life-threatening emergency or requiring surgery without delay to ensure survival,
- Patients receiving aminergic support before anesthetic induction,
- Patients treated with ACE inhibitors/ARBs who have not discontinued the treatment on the day of the procedure
Other illness
- 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,
Other
- \- 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 under general anesthesia before arrival in the operating room,
- Patients requiring rapid sequence induction,
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universty Hospital of Caen Coordinator of this site? Confirm its status | Caen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.