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

NCT01501643 | Terminated

• 1 other identifier: P091114
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell-hemoglobin SS Disease; Vaso-occlusive Crisis

Keywords

Non invasive positive pressure ventilation; Spirometry; Acute chest syndrome; Sickle cell disease; Vaso-occlusive crisis

Outcome Measures

Primary Outcomes (1)

• Occurence of acute chest syndrome

  up to 2 months at maximum (duration of hospitalization)

Secondary Outcomes (5)

• 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)

Study Arms (2)

Spirometry

ACTIVE COMPARATOR

Spirometry

Device: Spirometry

Non invasive positive pressure ventilation

EXPERIMENTAL

Non invasive positive pressure ventilation

Device: Non invasive positive pressure ventilation

Interventions

Non invasive positive pressure ventilation DEVICE

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

Non invasive positive pressure ventilation

Spirometry DEVICE

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

Spirometry

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker - Enfants Malades Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Acute Chest Syndrome

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Claire Heilbronner, MD, PhD

  Necker - Enfants Malades Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2011
• First Posted: December 29, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2015
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

FR (1)