Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT03502460
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2018-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2018-04-13', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apparition of Lines B at Lung Ultrasonography', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung ultrasonography', 'fluid administration', 'limitation', 'stroke volume variation', 'esophageal Doppler'], 'conditions': ['Surgery']}, 'referencesModule': {'references': [{'pmid': '35079044', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 ans\n* inclusion criteria:\n* Patient having a digestive, urological, gynecological, vascular or orthopedic surgery\n* Haemodynamic optimisation requiring titration of the fluid administration\n* Informed consent signed\n\nExclusion Criteria:\n\n* Non-consent\n* Chronic pulmonary pathology: COPD with pulmonary emphysema, pulmonary fibrosis'}, 'identificationModule': {'nctId': 'NCT03502460', 'acronym': 'ORFALU', 'briefTitle': 'Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Fluid Administration Limited by Lung Ultrasonography in the Operating Room: Correlation to Stroke Volume Variation (ORFALU)', 'orgStudyIdInfo': {'id': 'PI2017_843_0018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ORFALU', '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.\n\nEsophageal Doppler is a means of monitoring cardiac output measuring stroke volume (SV).', 'interventionNames': ['Other: Operating Room Fluid Administration Lung Ultrasound']}], 'interventions': [{'name': 'Operating Room Fluid Administration Lung Ultrasound', 'type': 'OTHER', 'description': 'Use of lung ultrasound to limited fluid administration', 'armGroupLabels': ['ORFALU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}