Preoperative Blood Volume Optimization Using Transthoracic Echocardiography
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity Hospital, Caen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
preoperative stroke volume optimization
Procedure/SurgeryStroke 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%
Post induction stroke volume optimization
Procedure/SurgeryOptimization 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%
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: controlActive comparator 1 intervention
Group B: preoperative echographyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
arterial hypotension
Incidence (%) of arterial hypotension (mean arterial pressure \< 65 mmHg) within 15 minutes following induction of general anesthesia. Blood pressure will be continuously measured using a radial arterial pressure catheter placed before induction of anesthesia in all patients.
Time frame
From enrollment to 15 min after orotracheal intubation during total intravenous anesthesiaSecondary outcomes
1
technical failure of preoperative stroke volume optimization
Proportion (%) of patients in whom volume preoperative stroke volume optimization could not be performed.
Time frame
From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia2
duration of arterial hypotension
Cumulative duration (in minutes) of arterial hypotension from the start of anesthetic drug administration until 15 minutes after orotracheal intubation
Time frame
From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia3
lowest mean arterial hypotension
Lowest mean arterial pressure (in mmHg)measured.
Time frame
From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia4
vasoactive drugs administration
Proportion (%) of patients requiring vasopressor during the measurement period.
Time frame
From enrollment to 15 min after orotracheal intubation during total intravenous anesthesiaSponsors and contacts
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Source ClinicalTrials.gov