Lung Ultrasound in Pediatric Acute Chest Syndrome

NCT06497153 | Recruiting

• 2 other identifiers: APHP240137IDRCB: 2023-A02741-44
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sickle-cell disease is a common disease with serious complications, in particular acute chest syndrome (ACS), which can be life threatening. The pathophysiology of ACS is poorly understood, but alveolar hypoventilation appears to play an important role. Pulmonary ultrasound is increasingly used in pediatrics to diagnose ACS. The management of ACS is complex, including oxygen therapy, antibiotics, spirometry, transfusions and ventilatory support. ACS and acute vaso-occlusive pain are the main reasons for hospitalisation in pediatric intensive care units. The aim of this study was to identify the pulmonary indicators correlated with ventilation time in these children, and to study the correlations between the results of lung ultrasound (LUS) and the clinical severity of the episode. The inclusion criteria for this study are the presence of an ACS in a child aged between 1 month and 17 years hospitalised in the pediatric intensive care unit at Robert-Debre Hospital who has not expressed any opposition and without opposition from their legal representative. The study will run for 2 years, with a target of 60 patients. Each patient included in the study will have multiple LUS during their care, in accordance with a protocol, and their clinical, biological and radiological data will be collected during their stay in the department.

Conditions

Sickle Cell Disease

Keywords

acute chest syndrome; lung ultrasound; LUS score; ventilation; clinical severity

Outcome Measures

Primary Outcomes (1)

• Correlation coefficients between LUS scores (lung ultrasound) at H0, H8, H24, H48, H72 and duration of ventilation (invasive and non-invasive combined)

  length of stay in intensive care unit (15 days)

Study Arms (1)

sickle cell anaemia patients with acute chest syndrome

Procedure: lung ultrasound

Interventions

lung ultrasound PROCEDURE

lung ultrasound repeated according to protocol during the stay in the paediatric intensive care unit

sickle cell anaemia patients with acute chest syndrome

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric Acute Chest Syndrome in sickle cell patients

You may qualify if:

• Sickle cell disease patient aged 1 month to 17 years
• Hospitalisation in the PICU of Robert-Debre hospital
• Suspicion of acute chest syndrome ACS
• No objection from a legal representative or the child taken in by the doctor.

You may not qualify if:

• Refusal of parents
• Delay between first LUS and initiation of ventilator support greater than 6 hours
• Patient without social insurance

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debré hOSPITAL

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Acute Chest Syndrome; Respiratory Aspiration

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; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aurélie HAYOTTE, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie HAYOTTE, MD

CONTACT

+33.1.40.03.36.49; aurelie.hayotte@aphp.fr

Michaël LEVY, MD, PhD

CONTACT

0140034098; michael.levy@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-06

Locations

FR (1)