Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00476866 |
| Other study ID # |
CIT-17 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
May 21, 2007 |
| Last updated |
May 21, 2007 |
| Start date |
December 2002 |
| Est. completion date |
March 2005 |
Study information
| Verified date |
May 2007 |
| Source |
University of Versailles |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
| Study type |
Interventional
|
Clinical Trial 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.
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
