TerminatedNot Applicable

Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease

Stopped: decision of the promoter

France6 participantsStarted 2011-11

Plain-language 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. 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.

Who can participate

Age range6 Years – 20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Occurence of acute chest syndrome

Timeframe: up to 2 months at maximum (duration of hospitalization)

Trial details

NCT IDNCT01501643

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11