Combined Use of Respiratory Devices After Thoracic Surgery

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510275
• Other study ID #: VP-02-2010
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: October 25, 2012
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Villa Pineta Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspnea
• Well Being

Intervention

Device:
• Combined use of RESPIVOL® and RESPILIFT®
Active devices (combined) for 14 consecutive session, bid, for 15 minutes.
• Combined use of RESPIVOL® and RESPILIFT®
Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.

Locations

Country	Name	City	State
Italy	Villa Pineta Hospital	Modena
Italy	Villa Pineta Hospital	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Villa Pineta Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle performance	Change of MEP (Maximum Expiratory Pressure)measure	Change from Baseline in MEP at 6 months	No
Secondary	Respiratory muscle performance	Change of MIP (Maximum Inspiratory Pressure)measure	Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No