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

Primary Purpose

Surgery

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Operating Room Fluid Administration Lung Ultrasound
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Surgery focused on measuring Lung ultrasonography, fluid administration, limitation, stroke volume variation, esophageal Doppler

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ORFALU

Arm Description

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).

Outcomes

Primary Outcome Measures

Apparition of Lines B at Lung Ultrasonography

Secondary Outcome Measures

Full Information

First Posted
April 13, 2018
Last Updated
January 10, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03502460
Brief Title
Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation.
Acronym
ORFALU
Official Title
Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation (ORFALU)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
Lung ultrasonography, fluid administration, limitation, stroke volume variation, esophageal Doppler

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORFALU
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Operating Room Fluid Administration Lung Ultrasound
Intervention Description
Use of lung ultrasound to limited fluid administration
Primary Outcome Measure Information:
Title
Apparition of Lines B at Lung Ultrasonography
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35079044
Citation
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.
Results Reference
derived

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

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