Sickle-Cell Disease Nos With CrisisECHO-STANCT03971136
Pulmonary Ultrasound in the Diagnosis of Acute Thoracic Syndrome in Vaso-occlusive Sickle Cell Crisis
A study testing pulmonary ultrasound in people with Sickle-Cell Disease Nos With Crisis, run by Centre Hospitalier Intercommunal Creteil at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Sickle-Cell Disease Nos With Crisis
- What is being tested?
- pulmonary ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 4 sitesFrance
- Study dates
- 4 Apr 2019to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Antoine Béclère
Clamart, 92141
Centre Hospitalier Intercommunal Créteil
Créteil, 94000
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Armand Trousseau
Paris, 75012
About this study
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
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.
Read the 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.
- Conditions
- Sickle-Cell Disease Nos With Crisis
- Being tested
- pulmonary ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary ultrasoundDiagnostic test
The subjects will have an ultrasound on admission and on day 1, 2 and 3
| Study group | Role | What they receive |
|---|---|---|
| Children with sickle cell disease | Other | Child from 12 months to 18 years old admitted for vaso-occlusive crisis Receives: Diagnostic Test: pulmonary ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of pulmonary ultrasound
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
Measured: Day 1
Sensitivity of pulmonary ultrasound
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
Measured: Day 2
Sensitivity of pulmonary ultrasound
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
Measured: Day 3
Secondary outcomes (9)
Specificity of pulmonary ultrasound
Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 1
Measured: Day 1
Specificity of pulmonary ultrasound
Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 2
Measured: Day 2
Specificity of pulmonary ultrasound
Proportion of subjects with a positive pulmonary ultrasound among those with a negative chest X-ray at time t at day 3
Measured: Day 3
Sensitivity of pulmonary ultrasound in relation with 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
Measured: day -3 of ATS diagnosis
Sensitivity of pulmonary ultrasound in relation with 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
Measured: day -1 of ATS diagnosis
Sensitivity of pulmonary ultrasound in relation with 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
Measured: day -2 of ATS diagnosis
Specificity of pulmonary ultrasound in relation with 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
Measured: day -1 of ATS diagnosis
Specificity of pulmonary ultrasound in relation with 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
Measured: -3 day of ATS diagnosis
Specificity of pulmonary ultrasound in relation with 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
Measured: day -2 of ATS diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start4 Apr 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle-Cell Disease Nos With CrisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971136
- Sponsor's protocol ID
- ECHO-STA
- Acronym
- ECHO-STA
- Status last verified
- Feb 2023
- First submitted
- 23 May 2019
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03971136
- Acronym / sponsor ID
- ECHO-STA / ECHO-STA
- Conditions
- Sickle-Cell Disease Nos With Crisis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with sickle cell disease | Other | Diagnostic Test: pulmonary ultrasoundChild from 12 months to 18 years old admitted for vaso-occlusive crisis |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary ultrasoundThe subjects will have an ultrasound on admission and on day 1, 2 and 3 | Diagnostic test | Children with sickle cell disease |
Primary outcome
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
9 secondary outcomes
Specificity of pulmonary ultrasound
Time frame: Day 1
Specificity of pulmonary ultrasound
Time frame: Day 2
Specificity of pulmonary ultrasound
Time frame: Day 3
Sensitivity of pulmonary ultrasound in relation with ATS diagnosis
Time frame: day -3 of ATS diagnosis
Sensitivity of pulmonary ultrasound in relation with ATS diagnosis
Time frame: day -1 of ATS diagnosis
Sensitivity of pulmonary ultrasound in relation with ATS diagnosis
Time frame: day -2 of ATS diagnosis
Specificity of pulmonary ultrasound in relation with ATS diagnosis
Time frame: day -1 of ATS diagnosis
Specificity of pulmonary ultrasound in relation with ATS diagnosis
Time frame: -3 day of ATS diagnosis
Specificity of pulmonary ultrasound in relation with ATS diagnosis
Time frame: day -2 of ATS diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary ultrasound in people with Sickle-Cell Disease Nos With Crisis, run by Centre Hospitalier Intercommunal Creteil at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of pulmonary ultrasound (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.