Sickle Cell-hemoglobin SS DiseaseVPACSNCT01501643
Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease
A study testing Non invasive positive pressure ventilation and Spirometry in people with Sickle Cell-hemoglobin SS Disease and Vaso-occlusive Crisis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Acute chest syndrome is a severe respiratory complication of sickle cell disease. The standard prevention of this dangerous complication is spirometry in wich patient is required to take deep breaths trough a little device several times a day. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Sickle Cell-hemoglobin SS Disease, Vaso-occlusive Crisis
- What is being tested?
- Non invasive positive pressure ventilation and Spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Apr 2015
- 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 6 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient with SS or S-Beta sickle cell disease aged more than 6 years old and less then 20 years old
- Hospitalised since less then 24 hours for severe vaso-occlusive crisis (either peripheric localisation or thoracic crisis) with morphinic requirements according to local pain management protocol
- With a signed informed consent from the patient or his legal representative if the patient is under 18 years old
- Benefiting of the French social security system
Who cannot join
- Patient that has already participated in the study
- Oxygen requirements, pneumonia, acute chest syndrome or other condition necessitating non invasive ventilation on admission
- No understanding of spirometry or ventilation techniques
- Other condition that forbid the use of non invasive ventilation or spirometry as defined by french consensus conference (2006) on non invasive ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease With Vaso-occlusive Crisis and Morphinic Treatment
Acute chest syndrome is a severe respiratory complication of sickle cell disease.
The standard prevention of this dangerous complication is spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.
Read more
The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than spirometry and may improve pain and quality of sleep.
Children with vaso-occlusive crisis necessitating morphinic treatment will be randomly assigned with either spirometry or ventilation and the investigators will monitor for occurrence of acute chest syndrome, pain and quality of sleep.
Read the detailed description
Acute chest syndrome is a severe complication of sickle cell disease. Several factors can contribute to this complication including infections, vaso-occlusive crisis, important pain that may give shortness of breath and morphinic treatments as they may cause hypoventilation.
The standard prevention of this dangerous complication is incentive spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.
In patients who have had surgery who have also pain and morphinic treatments, non invasive ventilation have proven a good option for preventing pulmonary complications.
Besides, our experience in non invasive ventilation for treatment of acute chest syndrome show a good tolerance and efficiency. It also seems to help with pain management.
The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than incentive spirometry and may improve pain and quality of sleep.
After informed consent, patients aged from 6 to 20 years old with SS or S-Beta sickle cell disease with vaso-occlusive crisis necessitating morphinic treatment hospitalised in intensive care unit in Necker Hospital for Sick Children (Paris) will be randomly assigned with either spirometry or ventilation. It is a monocentric study.
Patients with acute chest syndrome, oxygen needs, pneumonia or other condition requiring ventilation at presentation will not be included.
Spirometry will be realised through volumetric devices, every two hours during the day with 10 maximum inspirations and at night if the patient is awake.
Non invasive ventilation will be applied through a nasal mask with VS III machines from Resmed®, at least one hour every four hour but may be maintained more if the patient chooses to or is asleep with the machine on.
The investigators will monitor for occurrence of acute chest syndrome, pain, morphinic requirements, length of hospital stay, comfort, quality of sleep The treatment will be continued until morphinic treatment is stopped. The investigators intend to include 60 patients in each arm to show a difference of 25% in the occurrence of acute chest syndrome (primary judgement criteria).
Acute chest syndrome will be defined according to the criteria used by Vichinsky (Vichinsky, E. P. et al. Acute chest syndrome in sickle cell disease: clinical presentation and course. Cooperative Study of Sickle Cell Disease. Blood 89, 1787-1792 (1997) The investigators will aslo compare morphinic requirements, length of hospital stay and quality of sleep as secondary judgment criteria.
- Being tested
- Non invasive positive pressure ventilation, Spirometry
- Keywords
- Non invasive positive pressure ventilation, Spirometry, Acute chest syndrome, Sickle cell disease, Vaso-occlusive crisis
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Acute Chest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive positive pressure ventilationDevice
At least one hour every four hour but may be maintained more if the patient chooses to or is asleep with the machine on.
SpirometryDevice
Every two hours during the day with 10 maximum inspirations and at night if the patient is awake
| Study group | Role | What they receive |
|---|---|---|
| Spirometry | Active comparator | Spirometry Receives: Device: Spirometry |
| Non invasive positive pressure ventilation | Experimental | Non invasive positive pressure ventilation Receives: Device: Non invasive positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of acute chest syndrome
Measured: up to 2 months at maximum (duration of hospitalization)
Secondary outcomes (5)
Pain
Measured: up to 2 months at maximum (duration of hospitalization)
Morphinic requirements
Measured: up to 2 months at maximum (duration of hospitalization)
Length of hospital stay
Measured: up to 2 months at maximum (duration of hospitalization)
Comfort
Measured: up to 2 months at maximum (duration of hospitalization)
Quality of sleep
Measured: up to 2 months at maximum (duration of hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionApr 2015
Why it stopped: decision of the promoter
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell-hemoglobin SS 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Claire Heilbronner, MD, PhD, Principal investigator, Necker - Enfants Malades Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501643
- Sponsor's protocol ID
- P091114
- Acronym
- VPACS
- Status last verified
- Feb 2026
- First submitted
- 26 Dec 2011
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease With Vaso-occlusive Crisis and Morphinic Treatment
- ClinicalTrials.gov ID
- NCT01501643
- Acronym / sponsor ID
- VPACS / P091114
- Keywords
- Non invasive positive pressure ventilation, Spirometry, Acute chest syndrome, Sickle cell disease, Vaso-occlusive crisis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: decision of the promoter
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Nov 2011 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 29 Dec 2011 (estimated)
- 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.
Acute chest syndrome is a severe respiratory complication of sickle cell disease.
The standard prevention of this dangerous complication is spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.
The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than spirometry and may improve pain and quality of sleep.
Children with vaso-occlusive crisis necessitating morphinic treatment will be randomly assigned with either spirometry or ventilation and the investigators will monitor for occurrence of acute chest syndrome, pain and quality of sleep.
Detailed description
Acute chest syndrome is a severe complication of sickle cell disease. Several factors can contribute to this complication including infections, vaso-occlusive crisis, important pain that may give shortness of breath and morphinic treatments as they may cause hypoventilation.
The standard prevention of this dangerous complication is incentive spirometry in wich patient is required to take deep breaths trough a little device several times a day. This treatment is compromised when pain in important or when the patient is asleep and cannot participate.
In patients who have had surgery who have also pain and morphinic treatments, non invasive ventilation have proven a good option for preventing pulmonary complications.
Besides, our experience in non invasive ventilation for treatment of acute chest syndrome show a good tolerance and efficiency. It also seems to help with pain management.
The investigators hypothesised that non invasive ventilation in wich patient have no effort to take might be a better prevention than incentive spirometry and may improve pain and quality of sleep.
After informed consent, patients aged from 6 to 20 years old with SS or S-Beta sickle cell disease with vaso-occlusive crisis necessitating morphinic treatment hospitalised in intensive care unit in Necker Hospital for Sick Children (Paris) will be randomly assigned with either spirometry or ventilation. It is a monocentric study.
Patients with acute chest syndrome, oxygen needs, pneumonia or other condition requiring ventilation at presentation will not be included.
Spirometry will be realised through volumetric devices, every two hours during the day with 10 maximum inspirations and at night if the patient is awake.
Non invasive ventilation will be applied through a nasal mask with VS III machines from Resmed®, at least one hour every four hour but may be maintained more if the patient chooses to or is asleep with the machine on.
The investigators will monitor for occurrence of acute chest syndrome, pain, morphinic requirements, length of hospital stay, comfort, quality of sleep The treatment will be continued until morphinic treatment is stopped. The investigators intend to include 60 patients in each arm to show a difference of 25% in the occurrence of acute chest syndrome (primary judgement criteria).
Acute chest syndrome will be defined according to the criteria used by Vichinsky (Vichinsky, E. P. et al. Acute chest syndrome in sickle cell disease: clinical presentation and course. Cooperative Study of Sickle Cell Disease. Blood 89, 1787-1792 (1997) The investigators will aslo compare morphinic requirements, length of hospital stay and quality of sleep as secondary judgment criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spirometry | Active comparator | Device: SpirometrySpirometry |
| Non invasive positive pressure ventilation | Experimental | Device: Non invasive positive pressure ventilationNon invasive positive pressure ventilation |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient with SS or S-Beta sickle cell disease aged more than 6 years old and less then 20 years old
- Hospitalised since less then 24 hours for severe vaso-occlusive crisis (either peripheric localisation or thoracic crisis) with morphinic requirements according to local pain management protocol
- With a signed informed consent from the patient or his legal representative if the patient is under 18 years old
- Benefiting of the French social security system
Key exclusion criteria (4 listed)
- Patient that has already participated in the study
- Oxygen requirements, pneumonia, acute chest syndrome or other condition necessitating non invasive ventilation on admission
- No understanding of spirometry or ventilation techniques
- Other condition that forbid the use of non invasive ventilation or spirometry as defined by french consensus conference (2006) on non invasive ventilation
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 |
|---|---|---|
| Non invasive positive pressure ventilationAt least one hour every four hour but may be maintained more if the patient chooses to or is asleep with the machine on. | Device | Non invasive positive pressure ventilation |
| SpirometryEvery two hours during the day with 10 maximum inspirations and at night if the patient is awake | Device | Spirometry |
Primary outcome
Occurence of acute chest syndrome
Time frame: up to 2 months at maximum (duration of hospitalization)
5 secondary outcomes
Pain
Time frame: up to 2 months at maximum (duration of hospitalization)
Morphinic requirements
Time frame: up to 2 months at maximum (duration of hospitalization)
Length of hospital stay
Time frame: up to 2 months at maximum (duration of hospitalization)
Comfort
Time frame: up to 2 months at maximum (duration of hospitalization)
Quality of sleep
Time frame: up to 2 months at maximum (duration of hospitalization)
Results and safety
The study was stopped early (reason given: decision of the promoter). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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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.
Claire Heilbronner, MD, PhD principal investigator
Necker - Enfants Malades Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive positive pressure ventilation and Spirometry in people with Sickle Cell-hemoglobin SS Disease and Vaso-occlusive Crisis, 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 4 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: stopped early, as of the sponsor's last update on 13 Feb 2026. 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?
The study was stopped early (reason given: decision of the promoter). Results are not available in the source record.
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?
Occurence of acute chest syndrome (time frame: up to 2 months at maximum (duration of hospitalization)). 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 13 Feb 2026.