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Clinical Trials/NCT06755385
NCT06755385
Not yet recruiting
Not Applicable

Pilot Study on the Value of Bedside Pleuropulmonary Ultrasound in Patients With Sickle Cell Disease Presenting With Vaso-occlusive Crisis.

University Hospital, Grenoble0 sites25 target enrollmentJanuary 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sickle Cell Disease
Sponsor
University Hospital, Grenoble
Enrollment
25
Primary Endpoint
Description of the proportion of patients with sickle cell disease in vasoocclusive crisis presenting at least one pleuropulmonary ultrasound abnormality at D0, between D2 and D5 during hospitalization and at D-1 of discharge.
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

Describe the proportion of patients with major sickle cell syndrome in vaso-occlusive crisis presenting at least one pleuropulmonary ultrasound abnormality during one of the ultrasounds performed at D0, between D2 and D5 during hospitalization and at D-1 of discharge.

We hypothesize that pleuropulmonary ultrasound will make it possible to detect the serious complications associated with vaso-occlusive crises in patients with major sickle cell syndrome earlier and more reliably, in departments where ultrasound tools are still underdeveloped, while avoiding the need for more conventional radiology examinations that cause radiation in multi-hospitalized patients.

Registry
clinicaltrials.gov
Start Date
January 2025
End Date
March 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient agreeing to participate in the study
  • Patient with sickle-cell disease consulted to the emergency department or hospitalized in a conventional internal medicine department for a clinical picture of severe vaso-occlusive crisis (CVO) requiring hospitalization.
  • Hospitalization in the internal medicine department
  • Possible re-inclusion in the event of a subsequent episode of severe CVO

Exclusion Criteria

  • Subject under guardianship or subject deprived of freedom.
  • Primary acute chest syndrom (not following a crisis)
  • Pulmonary pathologies interfering with pleuro-pulmonary echo analysis: pneumonectomy, pulmonary fibrosis.

Outcomes

Primary Outcomes

Description of the proportion of patients with sickle cell disease in vasoocclusive crisis presenting at least one pleuropulmonary ultrasound abnormality at D0, between D2 and D5 during hospitalization and at D-1 of discharge.

Time Frame: 30 days

Presence of abnormalities found during pleuropulmonary ultrasound scans performed in the medical department on D0, between D2 and D5 during hospitalization and on D-1 of discharge, in patients with major sickle cell syndrome presenting with vasoocclusive crisis, among the following: * Pulmonary condensations; * Pleural effusion: minimal, of moderate abundance (estimated volume \< 500mL) or of great abundance (estimated volume \> 500mL); * Confluent B lines (≥ 3 B lines per lung field).

Secondary Outcomes

  • Evaluate the association between the ultrasound image and the clinical picture(30 days)
  • Evaluate the association between the ultrasound image detected and the occurrence of acute chest syndrom.(30 days)
  • Evaluate the association between the ultrasound image detected and the severity of the acute chest syndrom(30 days)
  • Describe the evolution of abnormalities between visits at D0, between D2 and D5 (V1 and V2) during hospitalization and at D-1 of discharge, and their association with clinical evolution(30 days)
  • Assess the prognostic value of discharge pleuropulmonary ultrasound in relation to re-hospitalization, occurrence of acute chest syndrom or early mortality (within 30 days)(30 days)

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