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

NCT06755385 | Not Yet Recruiting

• 1 other identifier: 38RC24.0347
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease; Pulmonary anomalies; Vaso-occlusive crisis; Acute chest syndrom; Pleuropulmonary ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  30 days

Secondary Outcomes (5)

• 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

Interventions

Pleuropulmonary ultrasound OTHER

pleuropulmonary ultrasounds performed at D0, between D2 and D5 during hospitalization and at D-1 on discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sickle cell disease hospitalized in the internal medicine department of Grenoble University Hospital for vasoocclusive crisis.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Related Publications (12)

• Arlet JB. [Sickle cell disease imposes itself to French internists in the 21st century]. Rev Med Interne. 2023 Jul;44(7):325-327. doi: 10.1016/j.revmed.2023.05.006. Epub 2023 May 26. No abstract available. French.

  PMID: 37246036 BACKGROUND

• Cheminet G, Mekontso-Dessap A, Pouchot J, Arlet JB. [Acute chest syndrome in adult sickle cell patients]. Rev Med Interne. 2022 Aug;43(8):470-478. doi: 10.1016/j.revmed.2022.04.019. Epub 2022 Jul 7. French.

  PMID: 35810055 BACKGROUND

• Vichinsky EP, Neumayr LD, Earles AN, Williams R, Lennette ET, Dean D, Nickerson B, Orringer E, McKie V, Bellevue R, Daeschner C, Manci EA. Causes and outcomes of the acute chest syndrome in sickle cell disease. National Acute Chest Syndrome Study Group. N Engl J Med. 2000 Jun 22;342(25):1855-65. doi: 10.1056/NEJM200006223422502.

  PMID: 10861320 BACKGROUND

• Castro O, Brambilla DJ, Thorington B, Reindorf CA, Scott RB, Gillette P, Vera JC, Levy PS. The acute chest syndrome in sickle cell disease: incidence and risk factors. The Cooperative Study of Sickle Cell Disease. Blood. 1994 Jul 15;84(2):643-9.

  PMID: 7517723 BACKGROUND

• Platt OS, Brambilla DJ, Rosse WF, Milner PF, Castro O, Steinberg MH, Klug PP. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med. 1994 Jun 9;330(23):1639-44. doi: 10.1056/NEJM199406093302303.

  PMID: 7993409 BACKGROUND

• Bartolucci P, Habibi A, Khellaf M, Roudot-Thoraval F, Melica G, Lascaux AS, Moutereau S, Loric S, Wagner-Ballon O, Berkenou J, Santin A, Michel M, Renaud B, Levy Y, Galacteros F, Godeau B. Score Predicting Acute Chest Syndrome During Vaso-occlusive Crises in Adult Sickle-cell Disease Patients. EBioMedicine. 2016 Aug;10:305-11. doi: 10.1016/j.ebiom.2016.06.038. Epub 2016 Jun 29.

  PMID: 27412264 BACKGROUND

• Lichtenstein D. Lung ultrasound in acute respiratory failure an introduction to the BLUE-protocol. Minerva Anestesiol. 2009 May;75(5):313-7.

  PMID: 19412150 BACKGROUND

• Razazi K, Deux JF, de Prost N, Boissier F, Cuquemelle E, Galacteros F, Rahmouni A, Maitre B, Brun-Buisson C, Mekontso Dessap A. Bedside Lung Ultrasound During Acute Chest Syndrome in Sickle Cell Disease. Medicine (Baltimore). 2016 Feb;95(7):e2553. doi: 10.1097/MD.0000000000002553.

  PMID: 26886600 BACKGROUND

• Koehl JL, Koyfman A, Hayes BD, Long B. High risk and low prevalence diseases: Acute chest syndrome in sickle cell disease. Am J Emerg Med. 2022 Aug;58:235-244. doi: 10.1016/j.ajem.2022.06.018. Epub 2022 Jun 11.

  PMID: 35717760 BACKGROUND

• Colla JS, Kotini-Shah P, Soppet S, Chen YF, Molokie R, Prajapati P, Prendergast HM. Bedside ultrasound as a predictive tool for acute chest syndrome in sickle cell patients. Am J Emerg Med. 2018 Oct;36(10):1855-1861. doi: 10.1016/j.ajem.2018.07.006. Epub 2018 Jul 3.

  PMID: 30017686 BACKGROUND

• Saah E, Lesnick BL. Lung Ultrasound in Sickle Cell: Sounds Like an Improvement in Acute Chest Diagnosis. Chest. 2023 Jun;163(6):1351-1352. doi: 10.1016/j.chest.2023.01.026. No abstract available.

  PMID: 37295874 BACKGROUND

• Torres-Macho J, Aro T, Bruckner I, Cogliati C, Gilja OH, Gurghean A, Karlafti E, Krsek M, Monhart Z, Muller-Marbach A, Neves J, Sabio R, Serra C, Smallwood N, Tana C, Uyaroglu OA, Von Wowern F, Bosch FH; EFIM s ultrasound working group.. Point-of-care ultrasound in internal medicine: A position paper by the ultrasound working group of the European federation of internal medicine. Eur J Intern Med. 2020 Mar;73:67-71. doi: 10.1016/j.ejim.2019.11.016. Epub 2019 Dec 11.

  PMID: 31836177 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Perrine Dumanoir, Doctor

CONTACT

+33 (0)4 76 76 68 98; PDumanoir@chu-grenoble.fr

Bruna Ducotterd, Master degree

CONTACT

+33 (0)4 76 76 78 38; BDucotterd@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 1, 2025
• Study Start: January 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12