Dyspnea, Well Being
Conditions
Keywords
cardio-thoracic surgery, patients, pulmonary volume, respiratory muscle performance
Brief summary
In a rehabilitation setting, respiratory muscle training with re-expansion techniques in patients following cardio-thoracic surgery represents a consolidated intervention. New devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent history of cardio-thoracic surgery.
Interventions
DEVICECombined use of RESPIVOL® and RESPILIFT®
Active devices (combined) for 14 consecutive session, bid, for 15 minutes.
Sponsors
Villa Pineta Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* \> 18 years old * recent cardio-thoracic surgery (\< 30 days of admission) * compliance to pulmonary rehabilitation program
Exclusion criteria
* clinical instability * concomitant severe co-morbidities * inability to use respiratory devices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory muscle performance | Change from Baseline in MEP at 6 months | Change of MEP (Maximum Expiratory Pressure)measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory muscle performance | Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m) | Change of MIP (Maximum Inspiratory Pressure)measure |
| Pulmonary volumes | Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m) | Change of Static and dynamic volumes (FEV1,FVC,VC,IC,RV) |
| Pulmonary gas exchange | Enrollment (T0), at the end (T14) and after 6 months (T6m) | Change of arterial oxygen(PaO2) and use of oxygen (FiO2) in terms of PaO2/FiO2 |
| Perceived dispnoea, well being and thoracic pain | At enrollment (T0), every day during the treatment (T2,T4, T6, T8, T10, T12), at the end (T14) and after 6 months (T6m) | Change of perceived dispnoea, well being and thoracic pain measured through validated Visual Analogic Scale (VAS) |
| Perceived quality of life | Enrollment (T0), at the end (T14) and after 6 months (T6m) | Change of perceived quality of life through Saint George Respiratory Questionnaire (SGRQ), italian version |
Countries
Italy
Outcome results
None listed