DyspneaNCT01510275
Combined Use of Respiratory Devices After Thoracic Surgery
A study testing Combined use of RESPIVOL® and RESPILIFT® in people with Dyspnea and Well Being, run by Villa Pineta Hospital at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Dyspnea, Well Being
- What is being tested?
- Combined use of RESPIVOL® and RESPILIFT®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old
- recent cardio-thoracic surgery (< 30 days of admission)
- compliance to pulmonary rehabilitation program
Who cannot join
- clinical instability
- concomitant severe co-morbidities
- inability to use respiratory devices
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Villa Pineta Hospital
Modena, Modena, 41026
Villa Pineta Hospital
Modena, Modena
About this study
Official title: 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.
- Conditions
- Dyspnea, Well Being
- Being tested
- Combined use of RESPIVOL® and RESPILIFT®
- Keywords
- cardio-thoracic surgery, patients, pulmonary volume, respiratory muscle performance
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined use of RESPIVOL® and RESPILIFT®Device
Active devices (combined) for 14 consecutive session, bid, for 15 minutes.
Combined use of RESPIVOL® and RESPILIFT®Device
Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Combined use of RESPIVOL® and RESPILIFT® (with resistive load) Receives: Device: Combined use of RESPIVOL® and RESPILIFT® |
| Control | Sham comparator | Combined use of RESPIVOL® and RESPILIFT® (without resistive load) Receives: Device: Combined use of RESPIVOL® and RESPILIFT® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory muscle performance
Change of MEP (Maximum Expiratory Pressure)measure
Measured: Change from Baseline in MEP at 6 months
Secondary outcomes (5)
Respiratory muscle performance
Change of MIP (Maximum Inspiratory Pressure)measure
Measured: Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)
Pulmonary volumes
Change of Static and dynamic volumes (FEV1,FVC,VC,IC,RV)
Measured: Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)
Pulmonary gas exchange
Change of arterial oxygen(PaO2) and use of oxygen (FiO2) in terms of PaO2/FiO2
Measured: Enrollment (T0), at the end (T14) and after 6 months (T6m)
Perceived dispnoea, well being and thoracic pain
Change of perceived dispnoea, well being and thoracic pain measured through validated Visual Analogic Scale (VAS)
Measured: 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
Change of perceived quality of life through Saint George Respiratory Questionnaire (SGRQ), italian version
Measured: Enrollment (T0), at the end (T14) and after 6 months (T6m)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Pineta Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Clini Enrico, Villa Pineta Hospital
- Investigators
- Enrico E Clini, MD, Study director, University of Modena - Ospedale Villa Pineta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510275
- Sponsor's protocol ID
- VP-02-2010
- Status last verified
- Oct 2012
- First submitted
- 10 Jan 2012
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23984352
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy on Combined Use of Respiratory Devices RESPILIFT® and RESPIVOL® in Adult Cardio-thoracic Surgery Patients. Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT01510275
- Acronym / sponsor ID
- VP-02-2010
- Conditions
- Dyspnea, Well Being
- Keywords
- cardio-thoracic surgery, patients, pulmonary volume, respiratory muscle performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Villa Pineta HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Combined use of RESPIVOL® and RESPILIFT®Combined use of RESPIVOL® and RESPILIFT® (with resistive load) |
| Control | Sham comparator | Device: Combined use of RESPIVOL® and RESPILIFT®Combined use of RESPIVOL® and RESPILIFT® (without resistive load) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old
- recent cardio-thoracic surgery (< 30 days of admission)
- compliance to pulmonary rehabilitation program
Key exclusion criteria (3 listed)
- clinical instability
- concomitant severe co-morbidities
- inability to use respiratory devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined use of RESPIVOL® and RESPILIFT®Active devices (combined) for 14 consecutive session, bid, for 15 minutes. | Device | Intervention |
| Combined use of RESPIVOL® and RESPILIFT®Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes. | Device | Control |
Primary outcome
Respiratory muscle performance
Time frame: Change from Baseline in MEP at 6 months
Change of MEP (Maximum Expiratory Pressure)measure
5 secondary outcomes
Respiratory muscle performance
Time frame: 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)
Pulmonary gas exchange
Time frame: 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)
Perceived quality of life
Time frame: Enrollment (T0), at the end (T14) and after 6 months (T6m)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
- Derived from this study: PubMed 23984352Crisafulli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrico E Clini, MD study director
University of Modena - Ospedale Villa Pineta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined use of RESPIVOL® and RESPILIFT® in people with Dyspnea and Well Being, run by Villa Pineta Hospital at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory muscle performance (time frame: Change from Baseline in MEP at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01510275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012.