Combined Use of Respiratory Devices After Thoracic Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy on Combined Use of Respiratory Devices RESPILIFT® and RESPIVOL® in Adult Cardio-thoracic Surgery Patients. Randomized-controlled Study

Conditions
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Dyspnea, Well Being

Intervention / Treatment
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* Device: Combined use of RESPIVOL® and RESPILIFT®
* Device: Combined use of RESPIVOL® and RESPILIFT®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Combined use of RESPIVOL® and RESPILIFT® (with resistive load) | Device: Combined use of RESPIVOL® and RESPILIFT®<br>* Active devices (combined) for 14 consecutive session, bid, for 15 minutes.<br>|
| Sham Comparator: Control<br>Combined use of RESPIVOL® and RESPILIFT® (without resistive load) | Device: Combined use of RESPIVOL® and RESPILIFT®<br>* Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle performance | Change of MEP (Maximum Expiratory Pressure)measure | Change from Baseline in MEP at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle performance | Change of MIP (Maximum Inspiratory Pressure)measure | Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m) | 
| Pulmonary volumes | Change of Static and dynamic volumes (FEV1,FVC,VC,IC,RV) | Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m) | 
| Pulmonary gas exchange | Change of arterial oxygen(PaO2) and use of oxygen (FiO2) in terms of PaO2/FiO2 | Enrollment (T0), at the end (T14) and after 6 months (T6m) | 
| Perceived dispnoea, well being and thoracic pain | Change of perceived dispnoea, well being and thoracic pain measured through validated Visual Analogic Scale (VAS) | At enrollment (T0), every day during the treatment (T2,T4, T6, T8, T10, T12), at the end (T14) and after 6 months (T6m) | 
| Perceived quality of life | Change of perceived quality of life through Saint George Respiratory Questionnaire (SGRQ), italian version | Enrollment (T0), at the end (T14) and after 6 months (T6m) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardio-thoracic surgery, patients, pulmonary volume, respiratory muscle performance