Diaphragm Training Post-Cardiac Surgery (DIATRACS)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||Randomized Controlled Trial on the Diaphragm Training With Threshold for Patient With Post-Cardiac Surgery Diaphragmatic Paralysis|
- chest x-ray mobility of the diaphragm [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- Maximal inspiratory pressure (MIP), cm H2O [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597298
|Trieste, TS, Italy, 34149|
|Study Director:||Maja Demsar, MD||AOUTS|
|Study Chair:||Marco Confaloniei, MD||AOUTS|