Combined Use of Respiratory Devices After Thoracic Surgery

• Sponsor: Villa Pineta Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01510275
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 30
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dyspnea; Well Being	Device: Combined use of RESPIVOL® and RESPILIFT®; Device: Combined use of RESPIVOL® and RESPILIFT®	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Efficacy on Combined Use of Respiratory Devices RESPILIFT® and RESPIVOL® in Adult Cardio-thoracic Surgery Patients. Randomized-controlled Study
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Combined use of RESPIVOL® and RESPILIFT® (with resistive load)	Device: Combined use of RESPIVOL® and RESPILIFT®; Active devices (combined) for 14 consecutive session, bid, for 15 minutes.
Sham Comparator: Control Combined use of RESPIVOL® and RESPILIFT® (without resistive load)	Device: Combined use of RESPIVOL® and RESPILIFT®; Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.

Outcome Measures

Primary Outcome Measures

1. Respiratory muscle performance [Change from Baseline in MEP at 6 months]

   Change of MEP (Maximum Expiratory Pressure)measure

Secondary Outcome Measures

1. Respiratory muscle performance [Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)]

   Change of MIP (Maximum Inspiratory Pressure)measure

2. 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)

3. 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

4. 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)

5. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Villa Pineta Hospital	Modena		Italy	41026
2	Villa Pineta Hospital	Modena		Italy

Sponsors and Collaborators

• Villa Pineta Hospital

Investigators

• Study Director: Enrico E Clini, MD, University of Modena - Ospedale Villa Pineta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Clini Enrico, Prof., Villa Pineta Hospital
• ClinicalTrials.gov Identifier: NCT01510275
• Other Study ID Numbers: VP-02-2010
• First Posted: Jan 16, 2012
• Last Update Posted: Oct 26, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by Prof. Clini Enrico, Prof., Villa Pineta Hospital: cardio-thoracic surgery; patients; pulmonary volume; respiratory muscle performance
• Additional relevant MeSH terms: Dyspnea

Study Results

No Results Posted as of Oct 26, 2012