Mitral Valve DiseaseNCT02278835
The Effectiveness of Respiratory Physiotherapy in Mitral Valve Surgery
A study testing breathing exercises, incentive spirometry and Intermittent positive pressure breathing in people with Mitral Valve Disease, run by University of Sao Paulo General Hospital.
Trial summary
This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques to prevent pulmonary collapse based in an score applied in the patients submitted of the mitral valve surgery, after their ICU discharge. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- breathing exercises, incentive spirometry and Intermittent positive pressure breathing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Sep 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients for mitral valve surgery, up to a maximum 2nd valve replacement
Who cannot join
- Patients unable to perform the functional tests
- Patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours
About this study
Official title: To Analyze the Effectiveness of Respiratory Physiotherapy Techniques in the Post Operative Mitral Valve
This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques to prevent pulmonary collapse based in an score applied in the patients submitted of the mitral valve surgery, after their ICU discharge.
Patients were allocated in groups according their pulmonary function (FVC: forced vital capacity), the respiratory muscle performance (MIP: maximal inspiratory pressure; MEP: maximal expiratory pressure), the oxygenation level (SpO2), the pulmonary auscultation; respiratory frequency (f); the ability to expectorate and the functional independence.
Read more
The group I was allocated those patients which presented decrease of up to 50% of forced vital capacity (FVC) of preoperative period, SpO2>92%, minimal pulmonary auscultation alterations; frequency (f) between 15 and 25 ipm; able to expectorate without assistance; independence to sit; respiratory. In these patients were randomized for two interventions: a) Deep breathing exercises: diaphragmatic exercises; inspiratory sighs; maximal inspiration exercises. Each kind of exercises was repeated 10 times; b) volume-targeted incentive spirometer: used Coach® three sets of 10 repetitions.
Patients allocated in the group II presented FVC> 30% <49% of preoperative period, ≥ 88% SpO2 <92%, necessity of oxygen therapy, abnormal pulmonary auscultation, f> 25 <31ipm; dependence to expectorate and to sit.. They were assisted by: a) Intermittent Positive Pressure Breathing (IPPB) with PEEP - through ventilator (Bird Mark 7™) with exhalation valve spring load set at 10 cmH2O. b) CPAP - 10 cmH2O associated with oxygen support to obtain SpO2≥ 95% with electronic device (Sullivan®) Each session consisted of 20 minutes, twice daily, one in the morning and another in the afternoon.
All of the patients were conducted in effort to mobilize upper and lower limbs. On the first day, the patients walked at least 50 meters, by increasing the distance to at least 150 meters on the fourth day. Outcome measures were recorded at day 5 of the interventions.
Read the detailed description
The study were conducted with individuals of both gender, aged between 18 and 60 years, candidates for mitral valve surgery, up to a maximum 2nd valve replacement. Patients unable to perform the functional tests were excluded and patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours .
- Conditions
- Mitral Valve Disease
- Being tested
- breathing exercises, incentive spirometry, Intermittent positive pressure breathing, Continuous positive airway pressure
- Keywords
- Cardiac valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breathing exercisesOther
Also called EXE
3 sets of 10 repetitions of deep breathing exercises
incentive spirometryDevice
Also called IS (Coach®)
3 sets of 10 repetitions of deep breathing exercises with incentive spirometry
Intermittent positive pressure breathingDevice
Also called IPPB (BIRD Mark 7™)
20 minutes breathing with intermittent positive pressure
Continuous positive airway pressureDevice
Also called CPAP (Sullivan®)
20 minutes breathing with continuous positive airway pressure
| Study group | Role | What they receive |
|---|---|---|
| level1 | Other | Patients classified in level 1 were randomized in the breathing exercises group or incentive spirometry group Receives: Other: breathing exercises; Device: incentive spirometry |
| level2 | Other | Patients classified in level 2 were randomized in the Intermittent Positive Pressure Breathing group or Continuous Positive Airway Pressure group Receives: Device: Intermittent positive pressure breathing; Device: Continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of atelectasis
Measured: Patients were followed for five days
Secondary outcomes (3)
pulmonary function
Forced vital capacity in liters and percentual (FVC; %FVC )
Measured: Patients were followed for five days
pulmonary function
Forced expiratory volume in first second in liters and percentual (FEV1; %FEV1)
Measured: Patients were followed for five days
pulmonary function
Ratio of forced expiratory volume in first second and forced vital capacity (FEV1/FVC)
Measured: Patients were followed for five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startMar 2009
- Primary completionJan 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Ignez Zanetti Feltrim, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278835
- Sponsor's protocol ID
- CAPPesq 0011/09
- Status last verified
- Oct 2014
- First submitted
- 2 Oct 2014
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Matte P, Jacquet L, Van Dyck M, Goenen M. Effects of conventional physiotherapy, continuous positive airway pressure and non-invasive ventilatory support with bilevel positive airway pressure after coronary artery bypass grafting. Acta Anaesthesiol Scand. 2000 Jan;44(1):75-81. doi: 10.1034/j.1399-6576.2000.440114.x.
PubMed 10669276Pasquina P, Tramer MR, Walder B. Prophylactic respiratory physiotherapy after cardiac surgery: systematic review. BMJ. 2003 Dec 13;327(7428):1379. doi: 10.1136/bmj.327.7428.1379.
PubMed 14670881
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Analyze the Effectiveness of Respiratory Physiotherapy Techniques in the Post Operative Mitral Valve
- ClinicalTrials.gov ID
- NCT02278835
- Acronym / sponsor ID
- CAPPesq 0011/09
- Conditions
- Mitral Valve Disease
- Keywords
- Cardiac valve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Oct 2014 (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.
This trial was conducted to evaluate the effectiveness of the chest physiotherapy techniques to prevent pulmonary collapse based in an score applied in the patients submitted of the mitral valve surgery, after their ICU discharge.
Patients were allocated in groups according their pulmonary function (FVC: forced vital capacity), the respiratory muscle performance (MIP: maximal inspiratory pressure; MEP: maximal expiratory pressure), the oxygenation level (SpO2), the pulmonary auscultation; respiratory frequency (f); the ability to expectorate and the functional independence.
The group I was allocated those patients which presented decrease of up to 50% of forced vital capacity (FVC) of preoperative period, SpO2>92%, minimal pulmonary auscultation alterations; frequency (f) between 15 and 25 ipm; able to expectorate without assistance; independence to sit; respiratory. In these patients were randomized for two interventions: a) Deep breathing exercises: diaphragmatic exercises; inspiratory sighs; maximal inspiration exercises. Each kind of exercises was repeated 10 times; b) volume-targeted incentive spirometer: used Coach® three sets of 10 repetitions.
Patients allocated in the group II presented FVC> 30% <49% of preoperative period, ≥ 88% SpO2 <92%, necessity of oxygen therapy, abnormal pulmonary auscultation, f> 25 <31ipm; dependence to expectorate and to sit.. They were assisted by: a) Intermittent Positive Pressure Breathing (IPPB) with PEEP - through ventilator (Bird Mark 7™) with exhalation valve spring load set at 10 cmH2O. b) CPAP - 10 cmH2O associated with oxygen support to obtain SpO2≥ 95% with electronic device (Sullivan®) Each session consisted of 20 minutes, twice daily, one in the morning and another in the afternoon.
All of the patients were conducted in effort to mobilize upper and lower limbs. On the first day, the patients walked at least 50 meters, by increasing the distance to at least 150 meters on the fourth day. Outcome measures were recorded at day 5 of the interventions.
Detailed description
The study were conducted with individuals of both gender, aged between 18 and 60 years, candidates for mitral valve surgery, up to a maximum 2nd valve replacement. Patients unable to perform the functional tests were excluded and patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| level1 | Other | Other: breathing exercises, Device: incentive spirometryPatients classified in level 1 were randomized in the breathing exercises group or incentive spirometry group |
| level2 | Other | Device: Intermittent positive pressure breathing, Device: Continuous positive airway pressurePatients classified in level 2 were randomized in the Intermittent Positive Pressure Breathing group or Continuous Positive Airway Pressure group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients for mitral valve surgery, up to a maximum 2nd valve replacement
Key exclusion criteria (2 listed)
- Patients unable to perform the functional tests
- Patients with signs of neurological disorders; hemodynamic instability, respiratory disorders and mechanically ventilated for more than 48 hours
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 |
|---|---|---|
| breathing exercisesAlso: EXE3 sets of 10 repetitions of deep breathing exercises | Other | level1 |
| incentive spirometryAlso: IS (Coach®)3 sets of 10 repetitions of deep breathing exercises with incentive spirometry | Device | level1 |
| Intermittent positive pressure breathingAlso: IPPB (BIRD Mark 7™)20 minutes breathing with intermittent positive pressure | Device | level2 |
| Continuous positive airway pressureAlso: CPAP (Sullivan®)20 minutes breathing with continuous positive airway pressure | Device | level2 |
Primary outcome
incidence of atelectasis
Time frame: Patients were followed for five days
3 secondary outcomes
pulmonary function
Time frame: Patients were followed for five days
pulmonary function
Time frame: Patients were followed for five days
pulmonary function
Time frame: Patients were followed for five days
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 30 Oct 2014.
- Background: PubMed 10669276Matte P, Jacquet L, Van Dyck M, Goenen M. Effects of conventional physiotherapy, continuous positive airway pressure and non-invasive ventilatory support with bilevel positive airway pressure after coronary artery bypass grafting. Acta Anaesthesiol Scand. 2000 Jan;44(1):75-81. doi: 10.1034/j.1399-6576.2000.440114.x.
- Results publication: PubMed 14670881Pasquina P, Tramer MR, Walder B. Prophylactic respiratory physiotherapy after cardiac surgery: systematic review. BMJ. 2003 Dec 13;327(7428):1379. doi: 10.1136/bmj.327.7428.1379.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing breathing exercises, incentive spirometry and Intermittent positive pressure breathing in people with Mitral Valve Disease, run by University of Sao Paulo General Hospital.
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 1 inclusion and 2 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 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
incidence of atelectasis (time frame: Patients were followed for five days). 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 NCT02278835, which also lists 2 linked publications.
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 30 Oct 2014.