Combined Use of Respiratory Devices After Thoracic Surgery

October 25, 2012 updated by: Prof. Clini Enrico, Villa Pineta Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41026
        • Villa Pineta Hospital
      • Modena, Italy
        • Villa Pineta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscle performance
Time Frame: Change from Baseline in MEP at 6 months
Change of MEP (Maximum Expiratory Pressure)measure
Change from Baseline in MEP at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)
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)
Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)
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
Enrollment (T0), at the end (T14) and after 6 months (T6m)
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)
At enrollment (T0), every day during the treatment (T2,T4, T6, T8, T10, T12), at the end (T14) and after 6 months (T6m)
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 (T0), at the end (T14) and after 6 months (T6m)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Villa Pineta Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 10, 2012

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimate)

January 16, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-02-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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