Actively Recruiting
Effect of Preoperative Stroke Volume Optimization Using Transthoracic Echocardiography on Arterial Hypotension Following Induction of Intravenous Anesthesia
Led by University Hospital, Caen · Updated on 2024-10-15
220
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether optimizing blood volume before surgery using transthoracic echocardiography (TTE) can reduce the incidence and severity of low blood pressure (arterial hypotension) following the start of general anesthesia. The study focuses on adult patients classified as ASA 3 or 4 who are undergoing intermediate or high-risk surgery. It is a prospective, randomized, controlled, double-blinded study comparing two approaches to stroke volume optimization during anesthesia induction. Participants are randomly assigned to either a standard care group, where stroke volume is optimized after anesthesia induction using an esophageal Doppler, or an experimental group receiving preoperative stroke volume optimization guided by TTE measuring the subaortic velocity time integral. Both groups undergo total intravenous anesthesia with drugs including propofol and remifentanil. Monitoring includes electrocardiogram, pulse oximetry, blood pressure via radial artery catheter, bispectral index for anesthesia depth, and neuromuscular blockade effects. Volume optimization involves guided administration of crystalloid fluids. During the study, patients undergo preoperative evaluation, including medical history and clinical exam, and a TTE either with or without volume optimization depending on their group. Data collected cover vital signs, stroke volume measurements, anesthesia drug dosing, blood pressure values, oxygen saturation, heart rate, and vasoactive drug use during anesthesia induction and 15 minutes afterward. The study ends shortly after this period and does not include long-term follow-up. The primary outcome is the occurrence of arterial hypotension (mean arterial pressure below 65 mmHg) within 15 minutes after intubation.
CONDITIONS
Brief 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 having signed the informed consent form
- Requires surgical intervention under general anesthesia
- Intermediate or high risk of cardiovascular events within 30 days
- ASA physical status Classification 3 or 4
You will not qualify if you...
- 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, Raynaud's syndrome, Buerger's disease, severe dyslipidemias
- Patients with conditions making ITVSAo measurement uninterpretable: atrial fibrillation, non-sinus electrocardiogram, severe valvulopathy, documented 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 stopped treatment on the day of the procedure
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of surgery
Participants undergo preoperative evaluation and receive stroke volume optimization using transthoracic echocardiography before induction of total intravenous anesthesia, followed by volume optimization after induction using esophageal Doppler monitoring during anesthesia.
1 baseline visit (preoperative evaluation and anesthesia induction)
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
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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