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Pulmonary Ultrasound in the Diagnosis of Acute Thoracic Syndrome in Vaso-occlusive Sickle Cell Crisis (ECHO-STA)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sickle-Cell Disease Nos With Crisis | Diagnostic Test: pulmonary ultrasound | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | 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 |
| Actual Study Start Date : | April 4, 2019 |
| Estimated Primary Completion Date : | June 3, 2021 |
| Estimated Study Completion Date : | December 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Children with sickle cell disease
Child from 12 months to 18 years old admitted for vaso-occlusive crisis
|
Diagnostic Test: pulmonary ultrasound
The subjects will have an ultrasound on admission and on day 1, 2 and 3
|
- 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
- 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
| Ages Eligible for Study: | 12 Months to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Camille JUNG, MD, PhD | +3357022268 | camille.jung@chicreteil.fr | |
| Contact: Fouad MADHI, MD | fouad.madhi@chicreteil.fr |
| France | |
| Hôpital Antoine Béclère | Not yet recruiting |
| Clamart, France, 92141 | |
| Contact: Mélanie TAVEIRA, MD melanie.taveira@aphp.fr | |
| Centre Hospitalier Intercommunal Créteil | Recruiting |
| Créteil, France, 94000 | |
| Contact: Fouad MADHI, MD fouad.madhi@chicreteil.fr | |
| Hôpital Bicêtre | Not yet recruiting |
| Le Kremlin-Bicêtre, France, 94270 | |
| Contact: Irina CRAIU, MD irina.craiu@aphp.fr | |
| Hôpital Armand Trousseau | Not yet recruiting |
| Paris, France, 75012 | |
| Contact: Guillaume Thouvenin, MD | |
| Contact: Céline Delestrain, MD celine.delestrain@aphp.fr | |
| 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 |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| 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. |
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| 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
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 12 Months to 17 Years (Child) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| 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 |
|
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| IPD Sharing Statement ICMJE |
|
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| 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 |
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