Combined Use of Respiratory Devices After Thoracic Surgery

Not Applicable

Completed

• Conditions: Dyspnea; Well Being
• Interventions: Device: Combined use of RESPIVOL® and RESPILIFT®

• Registration Number: NCT01510275
• Lead Sponsor: Villa Pineta Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-13
• Study First Posted: 2012-01-16
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Combined use of RESPIVOL® and RESPILIFT®	Combined use of RESPIVOL® and RESPILIFT® (with resistive load)
Control	Combined use of RESPIVOL® and RESPILIFT®	Combined use of RESPIVOL® and RESPILIFT® (without resistive load)

Primary Outcome Measures

Name	Time	Method
Respiratory muscle performance	Change from Baseline in MEP at 6 months	Change of MEP (Maximum Expiratory Pressure)measure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Villa Pineta Hospital; 🇮🇹 Modena, Italy