Optimizing blood volume before surgery using echocardiography
Effect of Preoperative Stroke Volume Optimization Using Transthoracic Echocardiography on Arterial Hypotension Following Induction of Intravenous Anesthesia. A Prospective, Double Blinded Randomized Study.
NA · University Hospital, Caen · NCT06639737
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Caen (other) |
| Locations | 1 site (Caen, Normandy) |
| Trial ID | NCT06639737 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, minors, or those with immediate life-threatening emergencies may not benefit from this study.
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 performed: Previous studies have shown promising results with similar approaches to optimizing hemodynamics in surgical patients, suggesting potential for success in this study.
Eligibility criteria
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 this trial is running
Caen, Normandy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anesthesia, Anesthesia Complication, Anesthesia Induction, Arterial Hypotension, preoperative stroke volume optimization echocardiography, arterial hypotension, general anesthesia, transoesophageal doppler