Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation.

NCT ID: NCT03502460

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2019-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Operating Room Fluid Administration Lung Ultrasound

Intervention Type OTHER

Use of lung ultrasound to limited fluid administration

Interventions

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Operating Room Fluid Administration Lung Ultrasound

Use of lung ultrasound to limited fluid administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 ans
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 35079044 (View on PubMed)

Other Identifiers

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PI2017_843_0018

Identifier Type: -

Identifier Source: org_study_id

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