Trial record 5 of 7 for:    Tethered Spinal Cord Syndrome

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

This study has been terminated.
(The number of patients desired has been reached)
Sponsor:
Information provided by:
University of Versailles
ClinicalTrials.gov Identifier:
NCT00476866
First received: May 21, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Central Cord Injury Syndrome
Central Spinal Cord Syndrome
Device: intermittent positive-pressure breathing (IPPB)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by University of Versailles:

Primary Outcome Measures:
  • Vital capacity, lung compliance and work of breathing [ Time Frame: 30 minutes after 2b months of treatment ]

Secondary Outcome Measures:
  • pulmonary function and blood gaz sample [ Time Frame: 30 minutes after 2 months of treatment ]

Enrollment: 14
Study Start Date: December 2002
Study Completion Date: March 2005
Detailed Description:

Patients The local ethics committee approved the study, and all patients have to give their written informed consent prior to inclusion. To be included patients had to satisfy the following criteria: (a) American Spinal Injury Association (ASIA) Class A or B10 SCI caused by trauma within the last 6 months and located between C5 and T6, (b) no thoracic injury, (c) and admission to a rehabilitation unit. The study was conducted over the first 4 months in the rehabilitation unit.

Measurements All tests will be performed with the patients seated in their wheelchairs. Lung function was tested using a Vmax 229 Sensormedics System (Yorba Linda, CA) according to standard guidelines.11 Arterial blood gas levels will be measured in capillary blood immediately after sampling from the radial artery with local anesthesia (topical lidocaine prilocaine, Emla®, Astra, Westborough, ME), using a Radiometer ABL 330 analyzer (Tacussel Radiometer Analytical, Copenhagen, Denmark). Flow will be measured using a Fleisch #2 pneumotachograph (Lausanne, Switzerland) and esophageal pressure (Pes) using a catheter-mounted pressure transducer system (Gaeltec, Dunvegan, UK). Appropriate placement will be verified by the occlusion test.12

Data Analysis Respiratory parameters will bemeasured during the last 5 minutes of a 20-minute period of relaxed breathing. From the flow tracings, we will measure inspiratory time (TI) and respiratory frequency (fR). Tidal volume (VT) will be obtained from the integrated flow signal. Dynamic lung compliance (CLdyn) will be calculated as the ratio of VT over the Pes difference at the points of zero flow corresponding to the start and end of inspiration.13 Inspiratory WOB (joule/min) will be calculated from a Campbell diagram by computing the area enclosed between the inspiratory Pes-VT curve and the theoretical static pressure-volume curve of the chest wall, as previously described.14 In addition, WOB will be partitioned into its elastic (WOBel) and resistive (WOBres) components on either side of the line joining the two zero-flow points.

Study protocol All patients will be studied during 2 months with and 2 months without IPPB, in random order. IPPB treatment will consist in at least 20 minutes of IPPB twice a day and 5 days a week. The patient will be comfortably seated with the back of the chair inclined at 45°. Inspiratory pressure will increase gradually to either the highest tolerated value or 40 cm H2O. Respiratory rate, inspiratory flow (from 20 to 60 L/min), and end-inspiratory trigger will be set to maximize patient comfort. The patients chose between a mouthpiece (Bird, Palm Springs, CA) and a nasal mask (Respironics, Herrsching, Germany). During both of the 2-month treatment periods, the number of patients who will require physiotherapy to clear excess secretions and the number of physiotherapy sessions per patient will be recorded.

Lung function tests will be performed at inclusion and at the end of each 2-month period in all patients. In addition, patients will be asked whether they will agree to measurements of flow, Pes, and gastric pressure at inclusion and at the end of each period. Measurements at the end of the IPPB period will be performed twice, immediately before and immediately after 20 minutes of IPPB with the catheter-mounted pressure-transducer system still in place. Each measurement period wil last about 5 minutes.

STATISTICS All data will be given as means±SD. Paired t tests will be used for within-patient comparisons of variables between the two treatments

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476866

Locations
France
Innovation Technological Center-Hôpital R. Poincaré
Garches, France, 92380
Sponsors and Collaborators
University of Versailles
Investigators
Principal Investigator: Frédéric Lofaso, MD PhD Assistance Publique-Hôpitaux de Paris and University of Versailles
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00476866     History of Changes
Other Study ID Numbers: CIT-17
Study First Received: May 21, 2007
Last Updated: May 21, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University of Versailles:
Paraplegia
tetraplegia
lung compliance
work of breathing
hyperinflation
rehabilitation

Additional relevant MeSH terms:
Retinitis Pigmentosa
Spinal Cord Injuries
Syndrome
Central Cord Syndrome
Spinal Cord Diseases
Neural Tube Defects
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Disease
Pathologic Processes
Nervous System Malformations
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 22, 2014