SurgeryORFALUNCT03502460
Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation.
A study testing Operating Room Fluid Administration Lung Ultrasound in people with Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The possibility of exploring the lungs by lung ultrasound, a non-invasive tool, is becoming increasingly popular for anesthesiologists. Recently, Lichtenstein has described the FALLS protocol (Fluid Administration Limited by Lung Sonography) which uses the potential of pulmonary ultrasound to evaluate early pulmonary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Operating Room Fluid Administration Lung Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 ans
- Patient having a digestive, urological, gynecological, vascular or orthopedic surgery
- Haemodynamic optimisation requiring titration of the fluid administration
- Informed consent signed
Who cannot join
- Non-consent
- Chronic pulmonary pathology: COPD with pulmonary emphysema, pulmonary fibrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation (ORFALU)
The possibility of exploring the lungs by lung ultrasound, a non-invasive tool, is becoming increasingly popular for anesthesiologists. Recently, Lichtenstein has described the FALLS protocol (Fluid Administration Limited by Lung Sonography) which uses the potential of pulmonary ultrasound to evaluate early pulmonary overload due to fluid administration at a subclinical stage. Indeed, fluid administration can generate a sub-clinical interstitial syndrome that can be detected by passing from a profile A to a profile B in lung ultrasound. The transition from a profile A to a profile B therefore corresponds to the transition from a state of preload dependent to a state of preload independence. However, this tool has not been studied in the operating room. The main objective of this study will be to study the correlation between pulmonary ultrasound and SV variation measured by esophageal Doppler during fluid administration in patients with haemodynamic optimisation in the operating room during digestive, urological, gynecological and orthopedic surgeries. The main expected result is the following: good correlation between the absence of increased SV in the esophageal Doppler and the appearance of a B-profile lung ultrasound fluid administration in the operating room.
- Conditions
- Surgery
- Being tested
- Operating Room Fluid Administration Lung Ultrasound
- Keywords
- Lung ultrasonography, fluid administration, limitation, stroke volume variation, esophageal Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operating Room Fluid Administration Lung UltrasoundOther
Use of lung ultrasound to limited fluid administration
| Study group | Role | What they receive |
|---|---|---|
| ORFALU | Other | Lung ultrasound consists of the application of a high-frequency ultrasound probe type Trans Thoracic Echography (ETT) on the anterior and lateral chest of the patient. Since air and bone do not pass through the US, it is the artefacts due to these structures that constitute ultrasound lung semiology.
Esophageal Doppler is a means of monitoring cardiac output measuring stroke volume (SV). Receives: Other: Operating Room Fluid Administration Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparition of Lines B at Lung Ultrasonography
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start31 May 2018
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
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
- NCT03502460
- Sponsor's protocol ID
- PI2017_843_0018
- Acronym
- ORFALU
- Status last verified
- Sep 2025
- First submitted
- 13 Apr 2018
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bar S, Yee C, Lichtenstein D, Sellier M, Leviel F, Abou Arab O, Marc J, Miclo M, Dupont H, Lorne E. Assessment of fluid unresponsiveness guided by lung ultrasound in abdominal surgery: a prospective cohort study. Sci Rep. 2022 Jan 25;12(1):1350. doi: 10.1038/s41598-022-05251-6.
PubMed 35079044
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation (ORFALU)
- ClinicalTrials.gov ID
- NCT03502460
- Acronym / sponsor ID
- ORFALU / PI2017_843_0018
- Conditions
- Surgery
- Keywords
- Lung ultrasonography, fluid administration, limitation, stroke volume variation, esophageal Doppler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 18 Apr 2018 (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 possibility of exploring the lungs by lung ultrasound, a non-invasive tool, is becoming increasingly popular for anesthesiologists. Recently, Lichtenstein has described the FALLS protocol (Fluid Administration Limited by Lung Sonography) which uses the potential of pulmonary ultrasound to evaluate early pulmonary overload due to fluid administration at a subclinical stage. Indeed, fluid administration can generate a sub-clinical interstitial syndrome that can be detected by passing from a profile A to a profile B in lung ultrasound. The transition from a profile A to a profile B therefore corresponds to the transition from a state of preload dependent to a state of preload independence. However, this tool has not been studied in the operating room. The main objective of this study will be to study the correlation between pulmonary ultrasound and SV variation measured by esophageal Doppler during fluid administration in patients with haemodynamic optimisation in the operating room during digestive, urological, gynecological and orthopedic surgeries. The main expected result is the following: good correlation between the absence of increased SV in the esophageal Doppler and the appearance of a B-profile lung ultrasound fluid administration in the operating room.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ORFALU | Other | Other: Operating Room Fluid Administration Lung UltrasoundLung ultrasound consists of the application of a high-frequency ultrasound probe type Trans Thoracic Echography (ETT) on the anterior and lateral chest of the patient. Since air and bone do not pass through the US, it is the artefacts due to these structures that constitute ultrasound lung semiology. Esophageal Doppler is a means of monitoring cardiac output measuring stroke volume (SV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 ans
- Patient having a digestive, urological, gynecological, vascular or orthopedic surgery
- Haemodynamic optimisation requiring titration of the fluid administration
- Informed consent signed
Key exclusion criteria (2 listed)
- Non-consent
- Chronic pulmonary pathology: COPD with pulmonary emphysema, pulmonary fibrosis
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 |
|---|---|---|
| Operating Room Fluid Administration Lung UltrasoundUse of lung ultrasound to limited fluid administration | Other | ORFALU |
Primary outcome
Apparition of Lines B at Lung Ultrasonography
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Results publication: PubMed 35079044Bar S, Yee C, Lichtenstein D, Sellier M, Leviel F, Abou Arab O, Marc J, Miclo M, Dupont H, Lorne E. Assessment of fluid unresponsiveness guided by lung ultrasound in abdominal surgery: a prospective cohort study. Sci Rep. 2022 Jan 25;12(1):1350. doi: 10.1038/s41598-022-05251-6.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operating Room Fluid Administration Lung Ultrasound in people with Surgery, 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 22 Sep 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparition of Lines B at Lung Ultrasonography (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502460, which also lists 1 linked publication.
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 22 Sep 2025.