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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03502460
Other study ID # PI2017_843_0018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2018
Est. completion date October 30, 2019

Study information

Verified date January 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date October 30, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Operating Room Fluid Administration Lung Ultrasound
Use of lung ultrasound to limited fluid administration

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Apparition of Lines B at Lung Ultrasonography 1 day
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