RecruitingNot ApplicableNCT06639737

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.


Sponsor

University Hospital, Caen

Enrollment

220 participants

Start Date

Oct 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria6

  • 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 Criteria12

  • \- 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

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Interventions

PROCEDUREpreoperative stroke volume optimization

Stroke volume optimization using transthoracic echocardigraphy (sub aortic velocity time integral) before induction of total intravenous anesthesia. Fluids bolus of 250 ml of cristalloids will be successively administered until the sub aortic velocity time integral increase will be \< 10%

PROCEDUREPost induction stroke volume optimization

Optimization of stroke volume following induction of general anesthesia using oesophageal stroke volume measurement. 250 ml bolus of cristalloids succesively administered until the stroke volume increase \<10%


Locations(1)

Universty Hospital of Caen

Caen, Normandy, France

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NCT06639737


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