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

Primary Purpose

Central Cord Injury Syndrome, Central Spinal Cord Syndrome

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
intermittent positive-pressure breathing (IPPB)
Sponsored by
University of Versailles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Cord Injury Syndrome focused on measuring Paraplegia, tetraplegia, lung compliance, work of breathing, hyperinflation, rehabilitation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Innovation Technological Center-Hôpital R. Poincaré

Outcomes

Primary Outcome Measures

Vital capacity, lung compliance and work of breathing

Secondary Outcome Measures

pulmonary function and blood gaz sample

Full Information

First Posted
May 21, 2007
Last Updated
May 21, 2007
Sponsor
University of Versailles
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1. Study Identification

Unique Protocol Identification Number
NCT00476866
Brief Title
Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury
Official Title
Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Terminated
Why Stopped
The number of patients desired has been reached
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Versailles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Cord Injury Syndrome, Central Spinal Cord Syndrome
Keywords
Paraplegia, tetraplegia, lung compliance, work of breathing, hyperinflation, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
intermittent positive-pressure breathing (IPPB)
Primary Outcome Measure Information:
Title
Vital capacity, lung compliance and work of breathing
Time Frame
30 minutes after 2b months of treatment
Secondary Outcome Measure Information:
Title
pulmonary function and blood gaz sample
Time Frame
30 minutes after 2 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Lofaso, MD PhD
Organizational Affiliation
Assistance Publique-Hôpitaux de Paris and University of Versailles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovation Technological Center-Hôpital R. Poincaré
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
3530648
Citation
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.
Results Reference
background
PubMed Identifier
15766917
Citation
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.
Results Reference
background
PubMed Identifier
18602082
Citation
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.
Results Reference
derived

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

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