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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Terminated

CT.gov ID

NCT01501643

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell-hemoglobin SS Disease Vaso-occlusive Crisis	Device: Non invasive positive pressure ventilation Device: Spirometry	N/A

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,

1. 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

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Non Invasive Positive Pressure Ventilation for Prevention of Acute Chest Syndrome in Sickle Cell Disease With Vaso-occlusive Crisis and Morphinic Treatment

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Nov 1, 2014

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Spirometry Spirometry	Device: Spirometry Every two hours during the day with 10 maximum inspirations and at night if the patient is awake
Experimental: Non invasive positive pressure ventilation Non invasive positive pressure ventilation	Device: Non invasive positive pressure ventilation At least one hour every four hour but may be maintained more if the patient chooses to or is asleep with the machine on.

Arm

Intervention/Treatment

Active Comparator: Spirometry

Spirometry

Device: Spirometry

Every two hours during the day with 10 maximum inspirations and at night if the patient is awake

Experimental: Non invasive positive pressure ventilation

Non invasive positive pressure ventilation

Device: Non invasive positive pressure ventilation

At least one hour every four hour but may be maintained more if the patient chooses to or is asleep with the machine on.

Outcome Measures

Primary Outcome Measures

Occurence of acute chest syndrome [up to 2 months at maximum (duration of hospitalization)]

Secondary Outcome Measures

Pain [up to 2 months at maximum (duration of hospitalization)]
Morphinic requirements [up to 2 months at maximum (duration of hospitalization)]
Length of hospital stay [up to 2 months at maximum (duration of hospitalization)]
Comfort [up to 2 months at maximum (duration of hospitalization)]
Quality of sleep [up to 2 months at maximum (duration of hospitalization)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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