Preoperative Blood Volume Optimization Using Transthoracic Echocardiography

NCT06639737 | Recruiting

• 1 other identifier: ID-RCB 2024-A01292-45
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia; Anesthesia Complication; Anesthesia Induction; Arterial Hypotension

Keywords

preoperative stroke volume optimization echocardiography; arterial hypotension; general anesthesia; transoesophageal doppler; sub aortic velocity time integral

Outcome Measures

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.

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

Secondary Outcomes (5)

• technical failure of preoperative stroke volume optimization

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

• duration of arterial hypotension

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

• lowest mean arterial hypotension

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

• vasoactive drugs administration

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

• cristalloids volume

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

Study Arms (2)

control

ACTIVE COMPARATOR

Standard care : total intravenous anesthesia followed by stroke volume optimization using oesophageal doppler

Procedure: Post induction stroke volume optimization

preoperative echography

EXPERIMENTAL

Stroke volume optimization using transthoracic echocardigraphy (sub aortic velocity time integral) before induction of total intravenous anesthesia

Procedure: preoperative stroke volume optimization

Interventions

preoperative stroke volume optimization PROCEDURE

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%

preoperative echography

Post induction stroke volume optimization PROCEDURE

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%

control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Universty Hospital of Caen

Caen, Normandy, 14000, France

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

jean-luc HANOUZ, MD PhD

CONTACT

02 31 06 47 36; hanouz-jl@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

FR (1)