Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00476866
Status:
TERMINATED
Last Update Posted:
2007-05-22
First Post:
2007-05-21
Brief Title:
Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury
Sponsor:
University of Versailles
Organization:
University of Versailles
Study Overview
Official Title:
Intermittent Positive-Pressure Breathing Effects in Patients With High Spinal Cord Injury
Status:
TERMINATED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The number of patients desired has been reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 guidelines11 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 test12
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 inspiration13 Inspiratory WOB joulemin 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 described14 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 Lmin 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 meansSD Paired t tests will be used for within-patient comparisons of variables between the two treatments
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 guidelines11 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 test12
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 inspiration13 Inspiratory WOB joulemin 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 described14 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 Lmin 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 meansSD Paired t tests will be used for within-patient comparisons of variables between the two treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None