Combined Use of Respiratory Devices After Thoracic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Clini Enrico, Villa Pineta Hospital
ClinicalTrials.gov Identifier:
NCT01510275
First received: January 10, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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 Intervention
Dyspnea
Well Being
Device: Combined use of RESPIVOL® and RESPILIFT®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Efficacy on Combined Use of Respiratory Devices RESPILIFT® and RESPIVOL® in Adult Cardio-thoracic Surgery Patients. Randomized-controlled Study

Further study details as provided by Villa Pineta Hospital:

Primary Outcome Measures:
  • Respiratory muscle performance [ Time Frame: Change from Baseline in MEP at 6 months ] [ Designated as safety issue: No ]
    Change of MEP (Maximum Expiratory Pressure)measure


Secondary Outcome Measures:
  • Respiratory muscle performance [ Time Frame: Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m) ] [ Designated as safety issue: No ]
    Change of MIP (Maximum Inspiratory Pressure)measure

  • Pulmonary volumes [ Time Frame: Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m) ] [ Designated as safety issue: No ]
    Change of Static and dynamic volumes (FEV1,FVC,VC,IC,RV)

  • Pulmonary gas exchange [ Time Frame: Enrollment (T0), at the end (T14) and after 6 months (T6m) ] [ Designated as safety issue: No ]
    Change of arterial oxygen(PaO2) and use of oxygen (FiO2) in terms of PaO2/FiO2

  • Perceived dispnoea, well being and thoracic pain [ 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) ] [ Designated as safety issue: No ]
    Change of perceived dispnoea, well being and thoracic pain measured through validated Visual Analogic Scale (VAS)

  • Perceived quality of life [ Time Frame: Enrollment (T0), at the end (T14) and after 6 months (T6m) ] [ Designated as safety issue: No ]
    Change of perceived quality of life through Saint George Respiratory Questionnaire (SGRQ), italian version


Enrollment: 60
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510275

Locations
Italy
Villa Pineta Hospital
Modena, Italy, 41026
Villa Pineta Hospital
Modena, Italy
Sponsors and Collaborators
Villa Pineta Hospital
Investigators
Study Director: Enrico E Clini, MD University of Modena - Ospedale Villa Pineta
  More Information

No publications provided by Villa Pineta Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Clini Enrico, Prof., Villa Pineta Hospital
ClinicalTrials.gov Identifier: NCT01510275     History of Changes
Other Study ID Numbers: VP-02-2010
Study First Received: January 10, 2012
Last Updated: October 25, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Villa Pineta Hospital:
cardio-thoracic surgery
patients
pulmonary volume
respiratory muscle performance

ClinicalTrials.gov processed this record on October 16, 2014