Lung Ultrasound-guided Hemodynamic Optimization

NCT05481723 | Recruiting Phase 3

• 1 other identifier: PI2021_843_0081
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Ultrasound; Goal Directed Therapy; Non-cardiac Surgery

Keywords

lung ultrasound; goal directed therapy; non-cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Number of Postoperative Organ failure

  Organ failure is defined according to the recommendations of the European Society of Anaesthesia (ESA)

  within 7 days

Secondary Outcomes (1)

• length of hospital stay

  7 days

Study Arms (2)

Control group

ACTIVE COMPARATOR

The control group will be treated according to the usual protocol of the department (standard group)

Drug: noradrenaline and vascular filling

pulmonary ultrasound group

EXPERIMENTAL

the experimental group follows an algorithm incorporating the number of B-lines occurring after a filling test (pulmonary ultrasound group).

Procedure: pulmonary ultrasound after vascular filling

Interventions

noradrenaline and vascular filling DRUG

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.

Control group

pulmonary ultrasound after vascular filling PROCEDURE

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%.

pulmonary ultrasound group

Eligibility Criteria

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

You may qualify if:

• Age\> 18 years old
• Abdominal, orthopaedic or vascular surgery with general anaesthesia
• Patient of legal age ≥ 18 years.
• ASA score ≥ II
• Estimated duration of surgery \> 2 hours
• At least two of the following comorbidities (age \> 50 years, hypertension, heart disease, electrocardiogram (ECG) abnormality, acute pulmonary oedema, smoking, stroke, peripheral arterial disease, non-insulin dependent or insulin dependent diabetes, ascites, chronic renal failure)
• Signed consent.
• Affiliation to a social security scheme.

You may not qualify if:

• Severe untreated or unbalanced hypertension on treatment.
• Preoperative renal failure on dialysis.
• Acute heart failure.
• Acute coronary insufficiency.
• Vascular surgery with renal plasty.
• Cardiac surgery.
• Preoperative shock.
• Refusal of patient participation.
• Pregnant, parturient or breastfeeding woman.
• Patient under guardianship or private law.
• Acute respiratory distress syndrome according to the Berlin definition
• respiratory distress not fully explained by cardiac failure or increased blood volume,
• PaO2/FiO2 ratio ≤ 300 mm Hg on mechanical ventilation (invasive or non-invasive)
• Chronic respiratory failure with home oxygen therapy.
• Chronic interstitial lung disease

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Stéphane BAR, DR

CONTACT

03 22 08 79 06; bar.stephane@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: July 28, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)