NCT03502460

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

April 13, 2018

Last Update Submit

September 17, 2025

Conditions

Keywords

Lung ultrasonographyfluid administrationlimitationstroke volume variationesophageal Doppler

Outcome Measures

Primary Outcomes (1)

  • Apparition of Lines B at Lung Ultrasonography

    1 day

Study Arms (1)

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).

Other: Operating Room Fluid Administration Lung Ultrasound

Interventions

Use of lung ultrasound to limited fluid administration

ORFALU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 ans
  • Patient having a digestive, urological, gynecological, vascular or orthopedic surgery
  • Haemodynamic optimisation requiring titration of the fluid administration
  • Informed consent signed

You may not qualify if:

  • Non-consent
  • Chronic pulmonary pathology: COPD with pulmonary emphysema, pulmonary fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 18, 2018

Study Start

May 31, 2018

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations