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| ID | Type | Description | Link |
|---|---|---|---|
| PN 001-08 |
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Diaphragm paralysis is a possible complication of cardiac surgery. The spontaneous recovery of the diaphragm mobility is slow and partial or absent in most cases. We hypothesize that a program of diaphragm muscle training by means of the Threshold variable resistance device could improve the rate of complete diaphragm mobility recovery in a shorter time period. Patient with post-cardiosurgical diaphragm paralysis will be random assigned to the specific training protocol or to a generic non-training physical activity.
Inclusion criteria: All consecutive patients aged from 18 to 80 years old with RX-defined diaphragm paralysis post a major cardiosurgery intervention such as coronary bypass, valve substitution or both.
Exclusion criteria: Acute cardiac failure, COPD, chronic respiratory failure with indication to home oxygen therapy, neuromuscular diseases.
Outcome measures: MIP, MEP, diaphragm function recovery assessed by chest X-ray, lung function tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | inspiratory muscle training program using a pressure threshold device |
|
| 2 | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Threshold | Device | Inspiratory muscle training program using a variable pressure device. An inspiratory muscle training device comprises a chamber having an opening for the passage of air to be inhaled and exhaled, and an inlet permitting air to be inhaled to enter the chamber and to pass to the opening. A one-way exhaust valve permits exhaled air entering through the opening to escape from the chamber, and another valve is provided to resist the entry of air to be inhaled into the chamber, the latter valve serving to vary the degree of resistance in dependence upon the volume of air that has passed through the inlet. |
| Measure | Description | Time Frame |
|---|---|---|
| chest x-ray mobility of the diaphragm | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal inspiratory pressure (MIP), cm H2O | 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maja Demsar, MD | AOUTS | Study Director |
| Marco Confaloniei, MD | AOUTS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fisiopatologia Respiratoria | Trieste | TS | 34149 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17658265 | Background | Versteegh MI, Braun J, Voigt PG, Bosman DB, Stolk J, Rabe KF, Dion RA. Diaphragm plication in adult patients with diaphragm paralysis leads to long-term improvement of pulmonary function and level of dyspnea. Eur J Cardiothorac Surg. 2007 Sep;32(3):449-56. doi: 10.1016/j.ejcts.2007.05.031. Epub 2007 Jul 19. | |
| 22938776 | Derived |
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| ID | Term |
|---|---|
| D012133 | Respiratory Paralysis |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D013069 | Speech Reception Threshold Test |
| ID | Term |
|---|---|
| D001302 | Audiometry, Speech |
| D001299 | Audiometry |
| D006320 | Hearing Tests |
| D003939 | Diagnostic Techniques, Otological |
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| sham threshold | Device | non-training physical activity |
|
| Kodric M, Trevisan R, Torregiani C, Cifaldi R, Longo C, Cantarutti F, Confalonieri M. Inspiratory muscle training for diaphragm dysfunction after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Mar;145(3):819-23. doi: 10.1016/j.jtcvs.2012.07.087. Epub 2012 Aug 29. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |