Sickle Cell DiseaseLupacsNCT06497153
Lung Ultrasound in Pediatric Acute Chest Syndrome
An observational study of Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- lung ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2024to 30 Sep 2026
- Phase
- Observational
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric Acute Chest Syndrome in sickle cell patients
Who may be able to join
- 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.
Who cannot join
- Refusal of parents
- Delay between first LUS and initiation of ventilator support greater than 6 hours
- Patient without social insurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Robert Debré hOSPITAL
Paris, 75019
Aurélie HAYOTTE, MD, +33.1.40.03.36.49, aurelie.hayotte@aphp.fr
Michaël LEVY, MD, PhD, 0140034098, michael.levy@aphp.fr
About this study
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.
Read the detailed description
Scientific rationale: Sickle-cell disease is a frequent disorder with a high morbidity. Its course is marked by acute complications with a life-threatening and functional prognosis, principally acute chest syndrome (ACS). This syndrome is caused by a combination of infection, fat embolism, and vaso-occlusion of the pulmonary vasculature. The pathophysiology of this syndrome is poorly understood, although alveolar hypoventilation plays an important role in its genesis. Pulmonary ultrasound is being used exponentially in pediatrics, and several studies have shown that it performs well in diagnosing ACS. Bedside lung ultrasound scans are now routinely performed in the management of patients with suspected or confirmed ACS. The management of ACS is multimodal, with the use of oxygen, antibiotics, incentive spirometry, transfusions, exchange transfusions and ventilatory assistance. Along with acute vaso-occlusive pain, ACS in children with sickle cell disease is the main reason for admission in pediatric intensive care. There are no recommendations concerning ventilatory support or transfusion in this situation. Lung parenchymal aeration and its evolution, as assessed by lung ultrasound, may allow patients to be categorised and ventilatory strategies and transfusion adapted.
Objective and primary endpoint:
- To identify the indicator of lung involvement assessed by LUS that best correlates with ventilation time in children with sickle cell disease admitted to the pediatric intensive care unit with suspected ACS.
Objectives and secondary endpoints:
- To study the correlation between LUS score and other markers of the clinical severity of the episode (invasive and non-invasive ventilation parameters, maximal FiO2, maximal PCO2, transfusion).
- To study the correlation between LUS score and clinical score (correlation with the Clinical Respiratory Score (CRS) and pulmonary auscultation).
- Conditions
- Sickle Cell Disease
- Being tested
- lung ultrasound
- Keywords
- acute chest syndrome, lung ultrasound, LUS score, ventilation, clinical severity
- Medical subject headings
- Anemia, Sickle Cell, Acute Chest Syndrome, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundProcedure or surgery
lung ultrasound repeated according to protocol during the stay in the paediatric intensive care unit
| Study group | Role | What they receive |
|---|---|---|
| sickle cell anaemia patients with acute chest syndrome | Not described Receives: Procedure: lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficients between LUS scores (lung ultrasound) at H0, H8, H24, H48, H72 and duration of ventilation (invasive and non-invasive combined)
Measured: length of stay in intensive care unit (15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start30 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie HAYOTTE, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497153
- Sponsor's protocol ID
- APHP240137
- Other IDs
- IDRCB: 2023-A02741-44
- Acronym
- Lupacs
- Status last verified
- Jun 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound in Pediatric Acute Chest Syndrome
- ClinicalTrials.gov ID
- NCT06497153
- Acronym / sponsor ID
- Lupacs / APHP240137
- Conditions
- Sickle Cell Disease
- Keywords
- acute chest syndrome, lung ultrasound, LUS score, ventilation, clinical severity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 11 Jul 2024 (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.
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.
Detailed description
Scientific rationale: Sickle-cell disease is a frequent disorder with a high morbidity. Its course is marked by acute complications with a life-threatening and functional prognosis, principally acute chest syndrome (ACS). This syndrome is caused by a combination of infection, fat embolism, and vaso-occlusion of the pulmonary vasculature. The pathophysiology of this syndrome is poorly understood, although alveolar hypoventilation plays an important role in its genesis. Pulmonary ultrasound is being used exponentially in pediatrics, and several studies have shown that it performs well in diagnosing ACS. Bedside lung ultrasound scans are now routinely performed in the management of patients with suspected or confirmed ACS. The management of ACS is multimodal, with the use of oxygen, antibiotics, incentive spirometry, transfusions, exchange transfusions and ventilatory assistance. Along with acute vaso-occlusive pain, ACS in children with sickle cell disease is the main reason for admission in pediatric intensive care. There are no recommendations concerning ventilatory support or transfusion in this situation. Lung parenchymal aeration and its evolution, as assessed by lung ultrasound, may allow patients to be categorised and ventilatory strategies and transfusion adapted.
Objective and primary endpoint:
- To identify the indicator of lung involvement assessed by LUS that best correlates with ventilation time in children with sickle cell disease admitted to the pediatric intensive care unit with suspected ACS.
Objectives and secondary endpoints:
- To study the correlation between LUS score and other markers of the clinical severity of the episode (invasive and non-invasive ventilation parameters, maximal FiO2, maximal PCO2, transfusion).
- To study the correlation between LUS score and clinical score (correlation with the Clinical Respiratory Score (CRS) and pulmonary auscultation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sickle cell anaemia patients with acute chest syndrome | – | Procedure: lung ultrasound |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric Acute Chest Syndrome in sickle cell patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Refusal of parents
- Delay between first LUS and initiation of ventilator support greater than 6 hours
- Patient without social insurance
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 |
|---|---|---|
| lung ultrasoundlung ultrasound repeated according to protocol during the stay in the paediatric intensive care unit | Procedure or surgery | sickle cell anaemia patients with acute chest syndrome |
Primary outcome
Correlation coefficients between LUS scores (lung ultrasound) at H0, H8, H24, H48, H72 and duration of ventilation (invasive and non-invasive combined)
Time frame: length of stay in intensive care unit (15 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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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.
Aurélie HAYOTTE, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélie HAYOTTE, MD (+33.1.40.03.36.49, aurelie.hayotte@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficients between LUS scores (lung ultrasound) at H0, H8, H24, H48, H72 and duration of ventilation (invasive and non-invasive combined) (time frame: length of stay in intensive care unit (15 days)). 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 11 Jul 2024.