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Combined Use of Respiratory Devices After Thoracic Surgery

Primary Purpose

Dyspnea, Well Being

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Combined use of RESPIVOL® and RESPILIFT®
Combined use of RESPIVOL® and RESPILIFT®
Sponsored by
Villa Pineta Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspnea focused on measuring cardio-thoracic surgery, patients, pulmonary volume, respiratory muscle performance

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Villa Pineta Hospital
  • Villa Pineta Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Control

Arm Description

Combined use of RESPIVOL® and RESPILIFT® (with resistive load)

Combined use of RESPIVOL® and RESPILIFT® (without resistive load)

Outcomes

Primary Outcome Measures

Respiratory muscle performance
Change of MEP (Maximum Expiratory Pressure)measure

Secondary Outcome Measures

Respiratory muscle performance
Change of MIP (Maximum Inspiratory Pressure)measure
Pulmonary volumes
Change of Static and dynamic volumes (FEV1,FVC,VC,IC,RV)
Pulmonary gas exchange
Change of arterial oxygen(PaO2) and use of oxygen (FiO2) in terms of PaO2/FiO2
Perceived dispnoea, well being and thoracic pain
Change of perceived dispnoea, well being and thoracic pain measured through validated Visual Analogic Scale (VAS)
Perceived quality of life
Change of perceived quality of life through Saint George Respiratory Questionnaire (SGRQ), italian version

Full Information

First Posted
January 10, 2012
Last Updated
October 25, 2012
Sponsor
Villa Pineta Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01510275
Brief Title
Combined Use of Respiratory Devices After Thoracic Surgery
Official Title
Efficacy on Combined Use of Respiratory Devices RESPILIFT® and RESPIVOL® in Adult Cardio-thoracic Surgery Patients. Randomized-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Villa Pineta Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Well Being
Keywords
cardio-thoracic surgery, patients, pulmonary volume, respiratory muscle performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Combined use of RESPIVOL® and RESPILIFT® (with resistive load)
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Combined use of RESPIVOL® and RESPILIFT® (without resistive load)
Intervention Type
Device
Intervention Name(s)
Combined use of RESPIVOL® and RESPILIFT®
Intervention Description
Active devices (combined) for 14 consecutive session, bid, for 15 minutes.
Intervention Type
Device
Intervention Name(s)
Combined use of RESPIVOL® and RESPILIFT®
Intervention Description
Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.
Primary Outcome Measure Information:
Title
Respiratory muscle performance
Description
Change of MEP (Maximum Expiratory Pressure)measure
Time Frame
Change from Baseline in MEP at 6 months
Secondary Outcome Measure Information:
Title
Respiratory muscle performance
Description
Change of MIP (Maximum Inspiratory Pressure)measure
Time Frame
Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)
Title
Pulmonary volumes
Description
Change of Static and dynamic volumes (FEV1,FVC,VC,IC,RV)
Time Frame
Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)
Title
Pulmonary gas exchange
Description
Change of arterial oxygen(PaO2) and use of oxygen (FiO2) in terms of PaO2/FiO2
Time Frame
Enrollment (T0), at the end (T14) and after 6 months (T6m)
Title
Perceived dispnoea, well being and thoracic pain
Description
Change of perceived dispnoea, well being and thoracic pain measured through validated Visual Analogic Scale (VAS)
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)
Title
Perceived quality of life
Description
Change of perceived quality of life through Saint George Respiratory Questionnaire (SGRQ), italian version
Time Frame
Enrollment (T0), at the end (T14) and after 6 months (T6m)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico E Clini, MD
Organizational Affiliation
University of Modena - Ospedale Villa Pineta
Official's Role
Study Director
Facility Information:
Facility Name
Villa Pineta Hospital
City
Modena
ZIP/Postal Code
41026
Country
Italy
Facility Name
Villa Pineta Hospital
City
Modena
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23984352
Citation
Crisafulli E, Venturelli E, Siscaro G, Florini F, Papetti A, Lugli D, Cerulli M, Clini E. Respiratory muscle training in patients recovering recent open cardiothoracic surgery: a randomized-controlled trial. Biomed Res Int. 2013;2013:354276. doi: 10.1155/2013/354276. Epub 2013 Jul 30.
Results Reference
derived

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Combined Use of Respiratory Devices After Thoracic Surgery

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