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AnesthesiaEchOptimalNCT06639737

Preoperative Blood Volume Optimization Using Transthoracic Echocardiography

A study testing preoperative stroke volume optimization and Post induction stroke volume optimization in people with Anesthesia and Anesthesia Complication, run by University Hospital, Caen at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
preoperative stroke volume optimization and Post induction stroke volume optimization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteFrance
Study dates
4 Oct 2024to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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,
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

jean-luc HANOUZ, MD PhD contact

02 31 06 47 36 ext. +33

hanouz-jl@chu-caen.fr

France1 site, 1 recruiting
  • Universty Hospital of Caen

    Caen, Normandy, 14000

    jean-luc hanouz, MD PhD, 0231064736 ext. +33, hanouz-jl@chu-caen.fr

    Kevin Dupont, MD

    Recruiting

Other trials in France

About this study

Official title: Effect of Preoperative Stroke Volume Optimization Using Transthoracic Echocardiography on Arterial Hypotension Following Induction of Intravenous Anesthesia. A Prospective, Double Blinded Randomized Study.

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.

Read more

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.
Read the detailed description

The pre-inclusion visit consists of a preoperative evaluation of the patient in the emergency operating room. This evaluation is conducted by an anesthesiologist for all patients requiring surgical care in the emergency operating room.

This evaluation is structured similarly to a pre-anesthetic consultation conducted by an anesthesiologist for scheduled surgery. During this preoperative evaluation, the patient's medical and surgical history, current treatments, and possible allergies are collected. A targeted clinical examination is also performed.

After this evaluation, the anesthesiologist analyzes the risks posed by the patient and the specific risks associated with surgery and anesthesia to define the best perioperative strategy.

Surgical interventions are classified into three categories of postoperative cardiovascular risk (low, intermediate, or high) for cardiovascular complications within 30 days post-surgery, according to the table provided by French and European recommendations.

During this consultation, patients eligible for the study (ASA classification 3 or 4, requiring general anesthesia for intermediate or high-risk surgery) will be identified.

After verifying the inclusion/exclusion criteria, the patient will be informed about the study, its course, objectives, and constraints.

An information letter will be given to the patient, and their informed consent will be collected in writing.

The pre-inclusion and inclusion visits will thus take place at the same time.

  1. Inclusion visit (V0):

This visit is conducted alongside the pre-inclusion visit:

  • Verification of inclusion/non-inclusion criteria by the investigator.
  • Patient information regarding the study, its procedures, constraints, and foreseeable risks.
  • Presentation of the information letter and obtaining of written informed consent after ensuring the patient's full understanding of the proposed protocol and answering all questions.
  • Collection of main medical history and concurrent treatments.
  • Clinical examination with vital signs.
  • Explanation of the study procedures.
  1. Practical implementation of the protocol - patient management:

After inclusion (as per paragraphs 1 and 2 above), all patients will undergo standard perioperative monitoring:

  • 5-lead electrocardiogram (IntelliVue MP 70, Philips HealthCare, Amsterdam, Netherlands).
  • Pulse oximetry.
  • Direct and continuous blood pressure measurement using a catheter inserted under local anesthesia into the radial artery (right or left), after verifying no contraindications. The catheter will be connected to a pressure transducer calibrated at the fifth intercostal space at the mid-axillary line.
  • Bispectral index (BIS™ Quatro Sensor, Covidien, Dublin, Ireland) to monitor anesthesia depth, keeping values within the recommended range (between 45 and 55).
  • Accelerometer (Philips IntelliVue NMT, Philips HealthCare, Amsterdam, Netherlands) placed on the thumb opposite the continuous blood pressure measurement site to monitor the effects of neuromuscular blocking agents (curare).

Before entering the operating room (in the recovery room of the emergency operating block), the patients will undergo the following:

  • Control group : A transthoracic echocardiography (TTE) without volume optimization, performed as recommended for preoperative evaluation of ventricular and valvular function. This TTE will be carried out by an experienced operator independent of the patient's care.
  • Experimental group : A TTE with volume optimization as explained earlier, performed by an experienced operator independent of the patient's care.

For all patients, the independent operator performing the TTE will share the collected data (ventricular and valvular function) with the anesthesiologist in charge of the patient. This data, which is important for patients with the included profile, will be collected as recommended and documented in a standardized report in the anesthesia consultation software.

In the operating room, the patient management will follow best practices for anesthesia and intensive care based on the patient profile, including:

  • Comfortable patient positioning and warming using a forced-air warming blanket (BairHugger™, 3M France, Cergy-Pontoise, France).
  • Pre-oxygenation with a target expired O2 fraction above 90% before induction of general anesthesia.
  • Induction of general anesthesia via intravenous injection using automated syringes with target-controlled anesthesia software with propofol and remifentanil. The depth of anesthesia will be adjusted according to the bispectral index values.
  • Administration of curare.
  • Orotracheal intubation and mechanical ventilation following perioperative protective ventilation recommendations adapted to the patient (FiO2 40%, tidal volume 6-8 mL/kg of ideal body weight, PEEP
  • 5 to +8 cmH2O).
  • Insertion of the esophageal Doppler probe (Cardio-Q, Gamida, Eaubonne, France) and urinary catheter.
  • Volume optimization for both groups following current recommendations, using stroke volume measurements from the esophageal Doppler and simultaneous measurement of the subaortic time-velocity integral (ITVSAo) with TTE.

Throughout the induction of anesthesia and during the 15 minutes corresponding to the collection of the primary outcome, an independent investigator not involved in patient care will record all the necessary data.

  1. Follow-up evaluations during the study (V1, V2, etc.): No additional blood samples are required for this study. A preoperative TTE called a "preoperative screening" (FOCUS exam) is proposed preoperatively for patients meeting the inclusion criteria of this study to evaluate their overall cardiac function before the intervention [15] (Class IIB, Level of Evidence B recommendation from the 2022 European Society of Cardiology guidelines on the assessment and management of patients undergoing non-cardiac surgery). As a result, the proportion of TTEs performed "in addition" compared to standard care will be minimal or none and can only be beneficial for preoperative assessment.

However, volume optimization is not routinely performed before the induction of general anesthesia as described earlier (in the summary and context paragraphs). This optimization does not require blood samples but involves a guided administration of crystalloids (currently, this administration is often empirical and not measured).

The echocardiography machines used will be those already present in the operating room (no additional equipment is required for this study).

  1. End-of-study evaluation: The follow-up ends 15 minutes after the completion of general anesthesia induction.

An analysis of all data between the start of induction and 15 minutes after the end of induction will be performed.

  1. Long-term follow-up evaluation: No long-term follow-up evaluation.
  2. Data to be collected

All data recorded by the monitoring devices of a patient during general anesthesia will be noted. This includes:

Before the induction of general anesthesia:

  • Data from the preoperative evaluation of the patient (age, weight, height, chronic conditions, chronic treatments, ASA classification, operative indication, systolic, diastolic, and mean blood pressure, heart rate, peripheral oxygen saturation).
  • TTE data including the subaortic time-velocity integral (ITVSAo).
  • Data on the volume optimization performed in the experimental group (volume of crystalloids administered, type of crystalloid, repeated measurements of ITVSAo, blood pressure, heart rate, peripheral oxygen saturation).
  • Time required for volume optimization (from the placement of the echocardiography probe to the end of the last administration of crystalloids).

During the induction of general anesthesia and for the 15 minutes following the initiation of controlled ventilation:

  • Maximum cerebral targets for propofol and remifentanil used with the target-controlled intravenous anesthesia syringe.
  • The highest and lowest systolic, diastolic, and mean blood pressure.
  • Duration during which a blood pressure < 65 mmHg is measured (since the blood pressure is measured continuously, this duration is assessed in 1-minute intervals).
  • The highest and lowest respiratory variation in pulse pressure.
  • The highest and lowest heart rate.
  • The highest and lowest oxygen saturation.
  • The highest and lowest expired CO2 levels.
  • The highest, lowest, and average bispectral index over 15 minutes.
  • Data from the volume optimization after the induction of general anesthesia obtained via esophageal Doppler (stroke volume, corrected ejection time, peak velocity), repeated measurements of blood pressure, heart rate, and peripheral oxygen saturation.
  • Volume of crystalloids administered for volume optimization after induction.
  • Vasopressor medications administered (name and total doses).
Being tested
preoperative stroke volume optimization, Post induction stroke volume optimization
Keywords
preoperative stroke volume optimization echocardiography, arterial hypotension, general anesthesia, transoesophageal doppler, sub aortic velocity time integral
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • preoperative stroke volume optimizationProcedure or surgery

    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%

  • Post induction stroke volume optimizationProcedure or surgery

    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%

Study groups in NCT06639737
Study groupRoleWhat they receive
controlActive comparatorStandard care : total intravenous anesthesia followed by stroke volume optimization using oesophageal doppler
Receives: Procedure: Post induction stroke volume optimization
preoperative echographyExperimentalStroke volume optimization using transthoracic echocardigraphy (sub aortic velocity time integral) before induction of total intravenous anesthesia
Receives: Procedure: preoperative stroke volume optimization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia

Secondary outcomes (5)
  1. technical failure of preoperative stroke volume optimization

    Proportion (%) of patients in whom volume preoperative stroke volume optimization could not be performed.

    Measured: From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia

  2. duration of arterial hypotension

    Cumulative duration (in minutes) of arterial hypotension from the start of anesthetic drug administration until 15 minutes after orotracheal intubation

    Measured: From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia

  3. lowest mean arterial hypotension

    Lowest mean arterial pressure (in mmHg)measured.

    Measured: From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia

  4. vasoactive drugs administration

    Proportion (%) of patients requiring vasopressor during the measurement period.

    Measured: From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia

  5. cristalloids volume

    Total volume of cristalloids require during the measurment period.

    Measured: From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2024
  2. Study start4 Oct 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06639737
Sponsor's protocol ID
ID-RCB 2024-A01292-45
Acronym
EchOptimal
Status last verified
Oct 2024
First submitted
10 Oct 2024
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing preoperative stroke volume optimization and Post induction stroke volume optimization in people with Anesthesia and Anesthesia Complication, run by University Hospital, Caen at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact jean-luc HANOUZ, MD PhD (02 31 06 47 36 ext. +33, hanouz-jl@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

arterial hypotension (time frame: From enrollment to 15 min after orotracheal intubation during total intravenous anesthesia). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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EchOptimal Clinical Trial NCT06639737 | AzTrials