Clinical Trial: Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease With Vaso-occlusive Crisis and Morphinic Treatment
Brief 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.
Detailed Summary:
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 vo
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Occurence of acute chest syndrome [ Time Frame: up to 2 months at maximum (duration of hospitalization) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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) ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: December 26, 2011
Date Started: November 2011
Date Completion:
Last Updated: April 9, 2015
Last Verified: April 2015
