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Combined Use of Respiratory Devices After Thoracic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510275
First Posted: January 16, 2012
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Clini Enrico, Villa Pineta Hospital
  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
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

Further study details as provided by Prof. Clini Enrico, Villa Pineta Hospital:

Primary Outcome Measures:
  • Respiratory muscle performance [ Time Frame: Change from Baseline in MEP at 6 months ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 10, 2012
First Posted: January 16, 2012
Last Update Posted: October 26, 2012
Last Verified: October 2012

Keywords provided by Prof. Clini Enrico, Villa Pineta Hospital:
cardio-thoracic surgery
patients
pulmonary volume
respiratory muscle performance

Additional relevant MeSH terms:
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms


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