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RecruitingNCT05481723POINTBARUpdated May 28, 2025

Lung Ultrasound-guided Hemodynamic Optimization

A Phase 3 interventional study of noradrenaline and vascular filling and pulmonary ultrasound after vascular filling in Lung Ultrasound, Goal Directed Therapy and Non-cardiac Surgery, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Ultrasound
  • Goal Directed Therapy
  • Non-cardiac Surgery

Keywords

  • lung ultrasound
  • goal directed therapy
  • non-cardiac surgery
03

In context

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, pleural calcifications, chest bandage, gunshot shrapnel...)
  • Participation in other interventional drug research.
  • Surgical fields covering the sites of investigation in lung ultrasound.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (estimated)

Study arms

  • Active comparator
    Control group

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

    Drug: noradrenaline and vascular filling

  • Experimental
    pulmonary ultrasound group

    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

  • 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%.

06

What researchers measure

Primary outcomes

  1. Number of Postoperative Organ failure

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

    Time frame: within 7 days

Secondary outcomes

  1. length of hospital stay

    Number of days staying in hospital

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05481723
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Aug 1, 2022
Start date
Jul 28, 2022
Primary completion
Jul 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
May 28, 2025

Study contacts

Stéphane BAR, DR
Contact
bar.stephane@chu-amiens.fr
03 22 08 79 06

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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