RecruitingPhase 3NCT05481723

Lung Ultrasound-guided Hemodynamic Optimization

Lung Ultrasound-guided Hemodynamic Optimization in Major Non-cardiac Surgery: a Randomized Control


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

350 participants

Start Date

Jul 28, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The formalized expert recommendation of the French Society of Anesthesia and Intensive Care recommends guiding vascular filling by measuring the stroke volume (SV) in surgical patients considered at high risk. Vascular filling should be continued in the event of preload dependence and stopped in the event of the appearance of preload independence. The aim is to avoid vascular overload due to excessive vascular filling. The application of this recommendation has resulted in a reduction in postoperative morbidity, length of hospital stay and time to return to oral feeding. The superiority of this strategy is now being questioned and the predictive indices of response to vascular filling (static and dynamic) have many limitations. In addition, none of the cardiac output monitors are the gold standard for intraoperative use. Through the study of artefacts, lung ultrasound has been gaining ground over the last twenty years, particularly in cardiology, nephrology and intensive care. By analogy with radiological B-lines, ultrasound B-lines result from the reverberation of ultrasound on the subpleural inter-lobular septa thickened by oedema. The Fluid Administration Limited by Lung Sonography (FALLS) protocol, described by Lichtenstein et al, is defined as the visualisation of new B lines during a vascular filling test. If a B-line appears in an area where it was not present during vascular filling, the most likely diagnosis is hydrostatic overload of the subpleural interstitial septum. This appearance of B-lines occurs at a sub-clinical stage. The use of lung ultrasound could allow real-time assessment of vascular filling and its tolerance during the intraoperative period. The main objective of the study is to demonstrate a decrease in the incidence of postoperative complications (organ failure) (as defined by international guidelines) when using lung ultrasound-guided haemodynamic optimisation compared to standard optimisation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a lung ultrasound-guided approach to managing fluid levels during and after major surgery, to reduce complications such as pneumonia and organ failure. The technique uses ultrasound scans of the lungs to guide how much fluid the anesthesiology team gives during the operation. You may be eligible if: - You are 18 or older - You are scheduled for abdominal, orthopedic, or vascular surgery under general anesthesia lasting more than 2 hours - You have an ASA score of II or higher - You have at least 2 of the following: age over 50, hypertension, heart disease, ECG abnormality, prior lung edema, smoking, stroke, peripheral arterial disease, diabetes, ascites, or chronic kidney disease You may NOT be eligible if: - You have severe uncontrolled hypertension, acute heart failure, or an acute coronary event - You have acute respiratory distress syndrome (ARDS) or chronic lung disease requiring home oxygen - You are scheduled for cardiac surgery or renal artery surgery - You are pregnant, breastfeeding, or a parturient - You have interstitial lung disease or a barrier preventing lung ultrasound (e.g., pneumothorax, chest bandage) - You are participating in another drug research trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGnoradrenaline and vascular filling

In the control group, the haemodynamic management of the patients is done according to usual practice by maintaining blood pressure with noradrenaline and optimising stroke volume with vascular filling.

PROCEDUREpulmonary ultrasound after vascular filling

In the interventional group, intraoperative haemodynamic management is based on an algorithm that includes measurement of the number of B-lines appearing on pulmonary ultrasound after vascular filling. Monitoring of the stroke volume will also be performed in this group in order to stop the vascular filling if the ESV does not increase by more than 10%.


Locations(1)

CHU Amiens

Amiens, France

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NCT05481723


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