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Pulmonary Ultrasound in the Diagnosis of Acute Thoracic Syndrome in Vaso-occlusive Sickle Cell Crisis (ECHO-STA)

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ClinicalTrials.gov Identifier: NCT03971136
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : July 17, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date July 17, 2020
Actual Study Start Date  ICMJE April 4, 2019
Estimated Primary Completion Date June 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Sensitivity of pulmonary ultrasound [ Time Frame: Day 1 ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day 1
  • Sensitivity of pulmonary ultrasound [ Time Frame: Day 2 ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day 2
  • Sensitivity of pulmonary ultrasound [ Time Frame: Day 3 ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day 3
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • Specificity of pulmonary ultrasound [ Time Frame: Day 1 ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 1
  • Specificity of pulmonary ultrasound [ Time Frame: Day 2 ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 2
  • Specificity of pulmonary ultrasound [ Time Frame: Day 3 ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 3
  • Sensitivity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -3 of ATS diagnosis ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence intervalat day -3 of ATS diagnosis
  • Sensitivity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -1 of ATS diagnosis ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day -1 of ATS diagnosis
  • Sensitivity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -2 of ATS diagnosis ]
    Proportion of subjects with positive pulmonary ultrasound among those with a positive chest X-ray at time t with 95% confidence interval at day -2 of ATS diagnosis
  • Specificity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -1 of ATS diagnosis ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day -1 of ATS diagnosis
  • Specificity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: -3 day of ATS diagnosis ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day -3 of ATS diagnosis
  • Specificity of pulmonary ultrasound in relation with ATS diagnosis [ Time Frame: day -2 of ATS diagnosis ]
    Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day -2 of ATS diagnosis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulmonary Ultrasound in the Diagnosis of Acute Thoracic Syndrome in Vaso-occlusive Sickle Cell Crisis
Official Title  ICMJE Evaluation of the Interest of Pulmonary Ultrasound in the Diagnosis and Early Detection of Acute Thoracic Syndrome in Hospitalized Children for Vaso-occlusive Sickle Cell Crisis: Multicenter Prospective Study
Brief Summary

ATS (acute thoracic syndrome) refers to acute pulmonary involvement in a sickle cell patient. The diagnosis is based on the association of clinical signs (fever or respiratory symptoms) with a recent pulmonary infiltrate on the chest x-ray.

The main objective of the study is to evaluate the place of the pulmonary ultrasound for the diagnosis of ATS, in comparison with frontal chest x-ray.

Detailed Description

The ATS occurs in half of the cases during hospitalization for a VOC (Vaso Occlusive crisis). The morbidity of ATS is important (respiratory insufficiency, duration of hospitalization, stays in intensive care, brain complications, pain, hypoxia, long-term sequelae, etc.) but no study has shown the benefits of curative treatments such as transfusion ( recommended at the time of diagnosis and practiced by some teams) or noninvasive ventilation (practiced by other teams). The first step before studying curative treatments is to have tools for early detection of ATS. Recent studies show non-inferiority of pulmonary ultrasonography compared to radiography and thoracic computed tomography in the diagnosis of pulmonary condensation (in adults and children). In a study performed in sickle cell adults admitted for ATS, pulmonary ultrasound was more sensitive than X-ray in detecting images of pulmonary consolidations visible on the chest CT scan.

Daswani et al have also shown the value of pulmonary ultrasound in comparison with radiography in the detection of consolidation lesions, suggestive of STA, in febrile children or young adults with sickle cell disease. They showed a good sensitivity (87%) and specificity (94%) of the pulmonary ultrasound.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Sickle-Cell Disease Nos With Crisis
Intervention  ICMJE Diagnostic Test: pulmonary ultrasound
The subjects will have an ultrasound on admission and on day 1, 2 and 3
Study Arms  ICMJE Children with sickle cell disease
Child from 12 months to 18 years old admitted for vaso-occlusive crisis
Intervention: Diagnostic Test: pulmonary ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date June 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: ≥12 months and <18 years
  • Has a major sickle cell disease whatever the genotype
  • Admission to hospital for a febrile vaso-occlusive crisis (VOC) or not
  • Evolving at home for less than 48h
  • Concomitant treatment with hydroxycarbamide / hydroxyurea possible
  • Signed consent
  • Patients affiliated to a French social security scheme

Exclusion Criteria:

  • Child presenting an acute thoracic syndrome (ATS) from the outset at the admission
  • Child who presented an ATS in the month preceding the inclusion
  • Child in regular transfusion program or child who has received a hematopoietic stem cell transplant
  • Child hospitalized at least 5 times for VOC in the year preceding inclusion (psychic problems making difficult the evaluation of the pain)
  • Child who has already been included in the study during a previous VOC (each child participates in the study only once)
  • VOC evolving for more than 48 hours before admission to the emergency room
  • Acute splenic sequestration crisis at admission
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Camille JUNG, MD, PhD +3357022268 camille.jung@chicreteil.fr
Contact: Fouad MADHI, MD fouad.madhi@chicreteil.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971136
Other Study ID Numbers  ICMJE ECHO-STA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Intercommunal Creteil
Study Sponsor  ICMJE Centre Hospitalier Intercommunal Creteil
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP