Combined Use of Respiratory Devices After Thoracic Surgery

Villa Pineta Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dyspnea Well Being

Interventions

Combined use of RESPIVOL® and RESPILIFT®DEVICE

Active devices (combined) for 14 consecutive session, bid, for 15 minutes.

Combined use of RESPIVOL® and RESPILIFT®DEVICE

Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Villa Pineta Hospital

Modena, Modena, Italy

Villa Pineta Hospital

Modena, Modena, Italy

Outcomes

Primary Outcomes

Respiratory muscle performance

Change of MEP (Maximum Expiratory Pressure)measure

Time frame: Change from Baseline in MEP at 6 months

Secondary Outcomes

Respiratory muscle performance

Change of MIP (Maximum Inspiratory Pressure)measure

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: Enrollment (T0), at the end (T14) and after 6 months (T6m)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.