Combined Use of Respiratory Devices After Thoracic Surgery

Villa Pineta Hospital

Status: Completed

Conditions: Dyspnea; Well Being

Treatments: Device: Combined use of RESPIVOL® and RESPILIFT®

Study type: Interventional

Funder types: Other

Identifiers

NCT01510275

VP-02-2010

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intervention

Experimental group

Description:

Combined use of RESPIVOL® and RESPILIFT® (with resistive load)

Treatment:

Device: Combined use of RESPIVOL® and RESPILIFT®

Device: Combined use of RESPIVOL® and RESPILIFT®

Control

Sham Comparator group

Description:

Combined use of RESPIVOL® and RESPILIFT® (without resistive load)

Treatment:

Device: Combined use of RESPIVOL® and RESPILIFT®

Device: Combined use of RESPIVOL® and RESPILIFT®