Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation. (ORFALU)
September 17, 2025 updated by: Centre Hospitalier Universitaire, Amiens
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 ans
- inclusion criteria:
- Patient having a digestive, urological, gynecological, vascular or orthopedic surgery
- Haemodynamic optimisation requiring titration of the fluid administration
- Informed consent signed
Exclusion Criteria:
- Non-consent
- Chronic pulmonary pathology: COPD with pulmonary emphysema, pulmonary fibrosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: ORFALU
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). |
Use of lung ultrasound to limited fluid administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Apparition of Lines B at Lung Ultrasonography
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2018
Primary Completion (Actual)
October 30, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
April 13, 2018
First Submitted That Met QC Criteria
April 17, 2018
First Posted (Actual)
April 18, 2018
Study Record Updates
Last Update Posted (Estimated)
September 22, 2025
Last Update Submitted That Met QC Criteria
September 17, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2017_843_0018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.