Actively Recruiting
Preoperative Blood Volume Optimization Using Transthoracic Echocardiography
Led by University Hospital, Caen · Updated on 2024-10-15
220
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preoperative Blood Volume Optimization Using Transthoracic Echocardiography
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or older
- Affiliated with social security
- Informed about the study and have signed the informed consent form
- Requires surgical intervention under general anesthesia
- Classified as intermediate or high risk for cardiovascular events within 30 days after surgery
- ASA physical status Classification 3 or 4
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients under guardianship, curatorship, or other legal protections
- Minors
- Patients with contraindications to intravenous induction with Propofol and Remifentanil
- Patients not fasting at the time of surgery
- Patients needing immediate life-saving surgery without delay
- Patients with contraindications to arterial pressure catheter placement in the radial artery (including bilateral negative Allen's test, Raynaud's syndrome, Buerger's disease, severe dyslipidemias)
- Patients with conditions making subaortic velocity time integral measurement uninterpretable (atrial fibrillation, non-sinus ECG, severe valvulopathy, documented heart failure)
- Patients already under general anesthesia before arriving in the operating room
- Patients receiving aminergic support before anesthesia induction
- Patients requiring rapid sequence induction
- Patients treated with ACE inhibitors or ARBs who have not stopped treatment the day of the procedure
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universty Hospital of Caen
Caen, Normandy, France, 14000
Actively Recruiting
Research Team
J
jean-luc HANOUZ, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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