Lung UltrasoundPhase 3POINTBARNCT05481723
Lung Ultrasound-guided Hemodynamic Optimization
A Phase 3 study testing noradrenaline and vascular filling and pulmonary ultrasound after vascular filling in people with Lung Ultrasound and Goal Directed Therapy, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Ultrasound, Goal Directed Therapy, Non-cardiac Surgery
- What is being tested?
- noradrenaline and vascular filling and pulmonary ultrasound after vascular filling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2022to Aug 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Stéphane Bar, Dr, (33)322088371, bar.stephane@chu-amiens.fr
About this study
Official title: Lung Ultrasound-guided Hemodynamic Optimization in Major Non-cardiac Surgery: a Randomized Control
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
- Being tested
- noradrenaline and vascular filling, pulmonary ultrasound after vascular filling
- Keywords
- lung ultrasound, goal directed therapy, non-cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noradrenaline and vascular fillingDrug
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.
pulmonary ultrasound after vascular fillingProcedure or surgery
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%.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The control group will be treated according to the usual protocol of the department (standard group) Receives: 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). Receives: Procedure: pulmonary ultrasound after vascular filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Postoperative Organ failure
Organ failure is defined according to the recommendations of the European Society of Anaesthesia (ESA)
Measured: within 7 days
Secondary outcomes (1)
length of hospital stay
Number of days staying in hospital
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start28 Jul 2022
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481723
- Sponsor's protocol ID
- PI2021_843_0081
- Acronym
- POINTBAR
- Status last verified
- May 2025
- First submitted
- 28 Jul 2022
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound-guided Hemodynamic Optimization in Major Non-cardiac Surgery: a Randomized Control
- ClinicalTrials.gov ID
- NCT05481723
- Acronym / sponsor ID
- POINTBAR / PI2021_843_0081
- Conditions
- Lung Ultrasound, Goal Directed Therapy, Non-cardiac Surgery
- Keywords
- lung ultrasound, goal directed therapy, non-cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: noradrenaline and vascular fillingThe control group will be treated according to the usual protocol of the department (standard group) |
| pulmonary ultrasound group | Experimental | Procedure: pulmonary ultrasound after vascular fillingthe experimental group follows an algorithm incorporating the number of B-lines occurring after a filling test (pulmonary ultrasound group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- Severe untreated or unbalanced hypertension on treatment.
- Preoperative renal failure on dialysis.
- Acute heart failure.
- Acute coronary insufficiency.
- Vascular surgery with renal plasty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| noradrenaline and vascular fillingIn 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. | Drug | Control group |
| pulmonary ultrasound after vascular fillingIn 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%. | Procedure or surgery | pulmonary ultrasound group |
Primary outcome
Number of Postoperative Organ failure
Time frame: within 7 days
Organ failure is defined according to the recommendations of the European Society of Anaesthesia (ESA)
1 secondary outcome
length of hospital stay
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing noradrenaline and vascular filling and pulmonary ultrasound after vascular filling in people with Lung Ultrasound and Goal Directed Therapy, run by Centre Hospitalier Universitaire, Amiens 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 8 inclusion and 18 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 28 May 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Stéphane BAR, DR (03 22 08 79 06, bar.stephane@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Postoperative Organ failure (time frame: within 7 days). 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 28 May 2025.