Pulmonary Volumes After Cardiac SurgeryNCT01074957
Effects of Physical Therapy on Cardiac Surgery
A study testing Incentive Spirometry, Breath-Stacking Technique and Exercise in people with Pulmonary Volumes After Cardiac Surgery, run by Centro Universitário Augusto Motta.
Trial summary
Background: Although respiratory physiotherapy has been used in patients undergoing cardiac surgery, evidence lacks concerning its effectiveness. The aim of this study was to evaluate the efficacy of three physiotherapeutic protocols used to recover respiratory volumes in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Volumes After Cardiac Surgery
- What is being tested?
- Incentive Spirometry, Breath-Stacking Technique and Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Nov 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were not included if any of the following criteria was present:
- Informed consent could not be obtained
- Could not perform the preoperative tests
- Cognitive impairments to perform the IS
- Intolerance to the use of BS mask
Who cannot join
- Hemodynamic complications (intraoperative myocardial infarction
- Major blood loss
- Marked hypotension
- Reduced cardiac output requiring the use of an intra-aortic balloon pump or extraordinary use of medications) and intubation period longer than 72 hours following arrival in the intensive care unit
About this study
Official title: Effects of Physical Therapy on Pulmonary Volumes
Background: Although respiratory physiotherapy has been used in patients undergoing cardiac surgery, evidence lacks concerning its effectiveness. The aim of this study was to evaluate the efficacy of three physiotherapeutic protocols used to recover respiratory volumes in the postoperative period.
Methods: Thirty five patients were randomly allocated into three groups. Exercise group (E) was oriented to progressive mobilization. Incentive Spirometry group (IS) performed deep breathings using VoldyneTM, while Breath-Stacking group (BS) performed successive inspiratory efforts using a facial mask adapted to an unidirectional valve. Both BS and IS also performed progressive mobilization. Forced spirometry was carried out in the pre-operative period and from the first to the fifth postoperative day. Statistical analysis used student t-test and ANOVA, and the differences were considered significant when p<0.05.
Read the detailed description
This was a prospective, controlled and randomized clinical trial, conducted with patients undergoing cardiac surgery at Hospital de Força Aérea do Galeão (HFAG - Rio de Janeiro, RJ, Brazil). According to Helsinki declaration, the protocol was approved by UNISUAM Ethics Committee (process: 15/2007) and written informed consent was obtained from all participants. All patients at the HFAG, who were scheduled for cardiac surgery between November 2007 and February 2009 were eligible to participate in this study.
Patients were not included if any of the following criteria was present: informed consent could not be obtained, they could not perform the preoperative tests, cognitive impairments to perform the IS, intolerance to the use of BS mask. Exclusion criteria included: hemodynamic complications (intraoperative myocardial infarction, major blood loss, marked hypotension, reduced cardiac output requiring the use of an intra-aortic balloon pump or extraordinary use of medications) and intubation period longer than 72 hours following arrival in the intensive care unit. In all patients the surgical procedure was through a median sternotomy, and the postoperative routine was the same, including optimal treatment for pain control. A verbal pain score was obtained using a visual analog scale and all patients initiated the physiotherapeutic treatment at the first postoperative day, following extubation. Demographic data, clinical history and preoperative risk factors were recorded.
In the preoperative period all patients were instructed about the importance of early mobilization and excessive bronchial secretion removal. Patients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day). Then, they were randomly allocated into three groups. Exercise group (E) performed only the procedures described above. Incentive Spirometry group (IS) was oriented to take a deep breathing through Voldyne 5000TM (Sherwood Medical; St Loius, MO, USA) from Functional Residual Capacity (FRC) to Total Lung Capacity (TLC). Breath-Stacking group (BS) performed inspiratory efforts using a facial mask adapted to an unidirectional valve. Since the mask was set to allow only inspiration (the expiratory branch was occluded), the patient carried through successive inspiratory efforts for a period of 20 seconds. Then, the expiratory branch was released allowing exhalation. These three treatments were applied for five days, with three series of five maneuvers twice a day. Patients management was similar among groups in terms of assessment, mobilization protocol and cough orientation.
For safety purposes, vital signs and oxygen saturation (SpO2) were monitored throughout the interventions. SpO2 was measured continuously for seven minutes using a portable pulse oximeter (Model 2500A, Nonin Medical INC; Plymouth, USA) with patient breathing room air. After seven minutes the most consistent value for 30 seconds was recorded and previous oxygen therapy was reinitiated. If during the assessment, patient's SpO2 dropped to below 85%, oxygen was recommenced and it was registered.
All procedures were performed under the supervision of an experienced physical therapist. Forced spirometry was carried out in the preoperative period and from the first to the fifth postoperative day, using a Pony Fx® spirometer (Cosmed; Rome, Italy). A Wright® ventilometer (British Oxygen Company; London, England) was properly attached to Voldyne and to Breath-Stacking mask, allowing to measure the Inspiratory Capacity (IC) during the procedures.
Postoperative risk was evaluated by means of Torrington Scale, using clinical and functional data.
Statistical Analysis Statistical analysis was done using Sigma Stat 3.1 (Jandel Scientific, San Rafael, CA, USA). Data are presented as average and standard error of the mean. They presented normal distributions (Kolmogorov-Smirnov test with Lilliefors' correction) and homogeneous variances (Levene median test). Comparisons of FVC between IS, BS and E were done with ANOVA, followed by Tukey test whenever multiple comparisons were required. Student's t-test was used to compare IC between IS and BS. The significance level was always set at 5%.
- Conditions
- Pulmonary Volumes After Cardiac Surgery
- Being tested
- Incentive Spirometry, Breath-Stacking Technique, Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive SpirometryDevice
Also called Voldyne
Incentive Spirometry (IS) has been used extensively in postoperative period and consists of spontaneous deep breaths through a device which provides a visual feedback to maintain a maximum insuflation
Breath-Stacking TechniqueDevice
Also called One-way inspiratory valve
An one-way valve device to promote the summation of successive inspiratory volumes while expiration was avoided
ExerciseOther
Also called Early mobilization
Patients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day).
| Study group | Role | What they receive |
|---|---|---|
| Incentive Spirometry | Active comparator | Incentive Spirometry group (IS) was oriented to take a deep breathing through Voldyne 5000TM (Sherwood Medical; St Loius, MO, USA) from Functional Residual Capacity (FRC) to Total Lung Capacity (TLC). Receives: Device: Incentive Spirometry |
| Exercise group | Active comparator | Patients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day). Receives: Other: Exercise |
| Breath-Stacking | Active comparator | Breath-Stacking group (BS) performed successive inspiratory efforts using a facial mask adapted to an unidirectional valve Receives: Device: Breath-Stacking Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory volume
Measured: First five postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startNov 2007
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Volumes After Cardiac SurgeryStudies 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Investigators
- Cristina M Dias, DSc, Principal investigator, Centro Universitário Augusto Motta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074957
- Sponsor's protocol ID
- UNISUAM
- Other IDs
- Mestrado UNISUAM
- Status last verified
- Feb 2010
- First submitted
- 22 Feb 2010
- Last updated
- 24 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Therapy on Pulmonary Volumes
- ClinicalTrials.gov ID
- NCT01074957
- Acronym / sponsor ID
- UNISUAM
- Conditions
- Pulmonary Volumes After Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 24 Feb 2010 (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.
Background: Although respiratory physiotherapy has been used in patients undergoing cardiac surgery, evidence lacks concerning its effectiveness. The aim of this study was to evaluate the efficacy of three physiotherapeutic protocols used to recover respiratory volumes in the postoperative period.
Methods: Thirty five patients were randomly allocated into three groups. Exercise group (E) was oriented to progressive mobilization. Incentive Spirometry group (IS) performed deep breathings using VoldyneTM, while Breath-Stacking group (BS) performed successive inspiratory efforts using a facial mask adapted to an unidirectional valve. Both BS and IS also performed progressive mobilization. Forced spirometry was carried out in the pre-operative period and from the first to the fifth postoperative day. Statistical analysis used student t-test and ANOVA, and the differences were considered significant when p<0.05.
Detailed description
This was a prospective, controlled and randomized clinical trial, conducted with patients undergoing cardiac surgery at Hospital de Força Aérea do Galeão (HFAG - Rio de Janeiro, RJ, Brazil). According to Helsinki declaration, the protocol was approved by UNISUAM Ethics Committee (process: 15/2007) and written informed consent was obtained from all participants. All patients at the HFAG, who were scheduled for cardiac surgery between November 2007 and February 2009 were eligible to participate in this study.
Patients were not included if any of the following criteria was present: informed consent could not be obtained, they could not perform the preoperative tests, cognitive impairments to perform the IS, intolerance to the use of BS mask. Exclusion criteria included: hemodynamic complications (intraoperative myocardial infarction, major blood loss, marked hypotension, reduced cardiac output requiring the use of an intra-aortic balloon pump or extraordinary use of medications) and intubation period longer than 72 hours following arrival in the intensive care unit. In all patients the surgical procedure was through a median sternotomy, and the postoperative routine was the same, including optimal treatment for pain control. A verbal pain score was obtained using a visual analog scale and all patients initiated the physiotherapeutic treatment at the first postoperative day, following extubation. Demographic data, clinical history and preoperative risk factors were recorded.
In the preoperative period all patients were instructed about the importance of early mobilization and excessive bronchial secretion removal. Patients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day). Then, they were randomly allocated into three groups. Exercise group (E) performed only the procedures described above. Incentive Spirometry group (IS) was oriented to take a deep breathing through Voldyne 5000TM (Sherwood Medical; St Loius, MO, USA) from Functional Residual Capacity (FRC) to Total Lung Capacity (TLC). Breath-Stacking group (BS) performed inspiratory efforts using a facial mask adapted to an unidirectional valve. Since the mask was set to allow only inspiration (the expiratory branch was occluded), the patient carried through successive inspiratory efforts for a period of 20 seconds. Then, the expiratory branch was released allowing exhalation. These three treatments were applied for five days, with three series of five maneuvers twice a day. Patients management was similar among groups in terms of assessment, mobilization protocol and cough orientation.
For safety purposes, vital signs and oxygen saturation (SpO2) were monitored throughout the interventions. SpO2 was measured continuously for seven minutes using a portable pulse oximeter (Model 2500A, Nonin Medical INC; Plymouth, USA) with patient breathing room air. After seven minutes the most consistent value for 30 seconds was recorded and previous oxygen therapy was reinitiated. If during the assessment, patient's SpO2 dropped to below 85%, oxygen was recommenced and it was registered.
All procedures were performed under the supervision of an experienced physical therapist. Forced spirometry was carried out in the preoperative period and from the first to the fifth postoperative day, using a Pony Fx® spirometer (Cosmed; Rome, Italy). A Wright® ventilometer (British Oxygen Company; London, England) was properly attached to Voldyne and to Breath-Stacking mask, allowing to measure the Inspiratory Capacity (IC) during the procedures.
Postoperative risk was evaluated by means of Torrington Scale, using clinical and functional data.
Statistical Analysis Statistical analysis was done using Sigma Stat 3.1 (Jandel Scientific, San Rafael, CA, USA). Data are presented as average and standard error of the mean. They presented normal distributions (Kolmogorov-Smirnov test with Lilliefors' correction) and homogeneous variances (Levene median test). Comparisons of FVC between IS, BS and E were done with ANOVA, followed by Tukey test whenever multiple comparisons were required. Student's t-test was used to compare IC between IS and BS. The significance level was always set at 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Incentive Spirometry | Active comparator | Device: Incentive SpirometryIncentive Spirometry group (IS) was oriented to take a deep breathing through Voldyne 5000TM (Sherwood Medical; St Loius, MO, USA) from Functional Residual Capacity (FRC) to Total Lung Capacity (TLC). |
| Exercise group | Active comparator | Other: ExercisePatients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day). |
| Breath-Stacking | Active comparator | Device: Breath-Stacking TechniqueBreath-Stacking group (BS) performed successive inspiratory efforts using a facial mask adapted to an unidirectional valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent could not be obtained
- Could not perform the preoperative tests
- Cognitive impairments to perform the IS
- Intolerance to the use of BS mask
Key exclusion criteria (4 listed)
- Hemodynamic complications (intraoperative myocardial infarction
- Major blood loss
- Marked hypotension
- Reduced cardiac output requiring the use of an intra-aortic balloon pump or extraordinary use of medications) and intubation period longer than 72 hours following arrival in the intensive care unit
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 |
|---|---|---|
| Incentive SpirometryAlso: VoldyneIncentive Spirometry (IS) has been used extensively in postoperative period and consists of spontaneous deep breaths through a device which provides a visual feedback to maintain a maximum insuflation | Device | Incentive Spirometry |
| Breath-Stacking TechniqueAlso: One-way inspiratory valveAn one-way valve device to promote the summation of successive inspiratory volumes while expiration was avoided | Device | Breath-Stacking |
| ExerciseAlso: Early mobilizationPatients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day). | Other | Exercise group |
Primary outcome
Respiratory volume
Time frame: First five postoperative 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 24 Feb 2010.
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.
Cristina M Dias, DSc principal investigator
Centro Universitário Augusto Motta
Questions about this trial
What is this clinical trial studying?
A study testing Incentive Spirometry, Breath-Stacking Technique and Exercise in people with Pulmonary Volumes After Cardiac Surgery, run by Centro Universitário Augusto Motta.
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 5 inclusion and 4 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 24 Feb 2010. 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?
Respiratory volume (time frame: First five postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2010.