Diaphragm Training Post-Cardiac Surgery (DIATRACS)
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|ClinicalTrials.gov Identifier: NCT00597298|
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : February 4, 2009
|Condition or disease||Intervention/treatment||Phase|
|Diaphragmatic Paralysis||Device: Threshold Device: sham threshold||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Active Comparator: 1
inspiratory muscle training program using a pressure 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.
|Sham Comparator: 2||
Device: sham threshold
non-training physical activity
- chest x-ray mobility of the diaphragm [ Time Frame: 6 and 12 months ]
- Maximal inspiratory pressure (MIP), cm H2O [ Time Frame: 6 and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597298
|Trieste, TS, Italy, 34149|
|Study Director:||Maja Demsar, MD||AOUTS|
|Study Chair:||Marco Confaloniei, MD||AOUTS|