Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury

NCT00476866 | Terminated

• 1 other identifier: CIT-17
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Central Cord Injury Syndrome; Central Spinal Cord Syndrome

Keywords

Paraplegia; tetraplegia; lung compliance; work of breathing; hyperinflation; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Vital capacity, lung compliance and work of breathing

  30 minutes after 2b months of treatment

Secondary Outcomes (1)

• pulmonary function and blood gaz sample

  30 minutes after 2 months of treatment

Interventions

intermittent positive-pressure breathing (IPPB) DEVICE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• thoracic injury

Sponsors & Collaborators

• University of Versailles: lead

Study Sites (1)

Innovation Technological Center-Hôpital R. Poincaré

Garches, 92380, France

Location

Related Publications (3)

• 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. doi: 10.1378/chest.90.4.546.

  PMID: 3530648 BACKGROUND

• Trebbia G, Lacombe M, Fermanian C, Falaize L, Lejaille M, Louis A, Devaux C, Raphael JC, Lofaso F. Cough determinants in patients with neuromuscular disease. Respir Physiol Neurobiol. 2005 Apr 15;146(2-3):291-300. doi: 10.1016/j.resp.2005.01.001.

  PMID: 15766917 BACKGROUND

• Laffont I, Bensmail D, Lortat-Jacob S, Falaize L, Hutin C, Le Bomin E, Ruquet M, Denys P, Lofaso F. Intermittent positive-pressure breathing effects in patients with high spinal cord injury. Arch Phys Med Rehabil. 2008 Aug;89(8):1575-9. doi: 10.1016/j.apmr.2007.12.037. Epub 2008 Jul 7.

  PMID: 18602082 DERIVED

MeSH Terms

Conditions

Central Cord Syndrome; Paraplegia; Quadriplegia

Interventions

Intermittent Positive-Pressure Breathing

Condition Hierarchy (Ancestors)

Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Frédéric Lofaso, MD PhD

  Assistance Publique-Hôpitaux de Paris and University of Versailles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 22, 2007
• Study Start: December 1, 2002
• Study Completion: March 1, 2005
• Last Updated: May 22, 2007

Record last verified: 2007-05

Locations

FR (1)