Central Spinal Cord Syndrome Clinical Trial
Official title:
Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury
Background: To determine whether intermittent positive-pressure breathing (IPPB) improved
lung compliance, work of breathing, and respiratory function in patients with recent high
spinal cord injury (SCI).
Methods: Two months of IPPB and two months of conventional treatment have to evaluated
prospectively in random order in 14 patients with SCI. Noninvasive lung function tests and
arterial blood gas measurements have to be obtained repeatedly. Repeated measurements of
dynamic compliance and work of breathing have to be performed in 7 of the 14 patients.
Status | Terminated |
Enrollment | 14 |
Est. completion date | March 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - American Spinal Injury Association (ASIA) Class A or B10 - SCI caused by trauma within the last 6 months and located between C5 and T6 - admission to a rehabilitation unit. Exclusion Criteria: - thoracic injury |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Innovation Technological Center-Hôpital R. Poincaré | Garches |
Lead Sponsor | Collaborator |
---|---|
University of Versailles |
France,
McCool FD, Mayewski RF, Shayne DS, Gibson CJ, Griggs RC, Hyde RW. Intermittent positive pressure breathing in patients with respiratory muscle weakness. Alterations in total respiratory system compliance. Chest. 1986 Oct;90(4):546-52. — View Citation
Trebbia G, Lacombe M, Fermanian C, Falaize L, Lejaille M, Louis A, Devaux C, Raphaël JC, Lofaso F. Cough determinants in patients with neuromuscular disease. Respir Physiol Neurobiol. 2005 Apr 15;146(2-3):291-300. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Vital capacity, lung compliance and work of breathing | 30 minutes after 2b months of treatment | ||
Secondary | pulmonary function and blood gaz sample | 30 minutes after 2 months of treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01367405 -
Comparing Surgical Decompression Versus Conservative Treatment in Incomplete Spinal Cord Injury
|
N/A |