Postoperative ComplicationsPhase 1NCT02054039
Incentive Spirometry and Breath Stacking
A Phase 1 study testing Incentive spirometry (IS) and Breath Stacking (BS) in people with Postoperative Complications, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Postoperative pulmonary complications in patients undergoing cardiac surgery are a major clinical problem, presenting negative impact on morbidity, mortality , length of hospital stay and health care costs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Incentive spirometry (IS) and Breath Stacking (BS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects admitted to the Hospital Santa Casa de Londrina (HSCL) with programming for cardiac surgery with cardiopulmonary bypass, age above 18 years, and referral for surgery by the study teams. Individuals must be aware, informed, and agreed to participate in the study, including signing of SIC
Who cannot join
- Individuals with cognitive impairment that prevents the implementation of spirometry (lung function ), manovacuometry (MIP and MEP) and incentive spirometry; below 18 years of age; patients with chronic obstructive pulmonary disease diagnosed by clinical history and spirometry ( FVC < 80 % of predicted and / or FEV1 < 70 % predicted); and individuals with a history of asthma.
- Patients will be withdrawn from the study and the Intention to Treat Analysis will be performed in the case of: patients who cannot be extubated because of the need for continuing mechanical ventilation after 24 hours of post-operative complications in the postoperative period; hemodynamic instability ; myocardial infarction during operation ; severe blood loss defined by the medical staff; loss of 20 % or more of total blood volume; mean arterial pressure (MAP ) < 70 mmHg; reduced cardiac output requiring the use of intra-aortic balloon or vasoactive drugs for more than 72 hours, after ICU admission or need for new reintubation. Patients who did not agree to participate by not signing the SIC
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Santa Casa de Londrina
Londrina, Paraná, 86020060
Eliane FS Freitas, PhD, 55+4399951354, elianefe@sercomtel.com.br
Eliane FS Freitas, PhD
About this study
Official title: Comparison Between Incentive Spirometry and Breath Stacking After Cardiac Surgery
- Postoperative pulmonary complications in patients undergoing cardiac surgery are a major clinical problem, presenting negative impact on morbidity, mortality , length of hospital stay and health care costs. Although physical therapy has been widely used as a resource to improve lung function in the postoperative period, the adoption of routine procedures of physical therapy needs be discussed.
- Incentive spirometers are mechanical devices used to reduce postoperative pulmonary complications. In general, they are activated by an inspiratory effort, visualized by an uplifted plate or ball in a transparent cylinder during sustained inspiration.
- Breath Stacking is a technique allowing the patient inhale a greater volume of air, kept for a longer period of time using a one-way valve, thus promoting the accumulation of successive inspiratory volume and preventing exhalation.
- The objective of the study is to evaluate the effectiveness of two different techniques of respiratory therapy on both reducing postoperative pulmonary complications and improving lung function.
- Type of study : randomized clinical trial
- Hypothesis
- Both techniques Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) and Breath Stacking ( BS ) may present similar effectiveness on reducing pulmonary complications, improving lung function and respiratory muscle strength ( MIP and MEP), as well as reducing hospital stay .
- Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) may be more effective than Breath Stacking on reducing pulmonary complications, improving lung function and respiratory muscle strength, as well as reducing hospital stay.
Read the detailed description
- Type of study : randomized clinical trial
- Study site: The study will be carried out at the Hospital Santa Casa de Londrina.
- Subjects: all patients scheduled for cardiac surgery will be studied ( CABG and / or valve replacement )
- Patients will be evaluated both preoperatively, and on the fifth postoperative day (POD). They will be informed about the procedures to which they will be submitted, as well as the objective of the proposed study preoperatively. If approved by the patient, the "Statement of Informed Consent - SIC" will be signed.
- Inclusion Criteria
- Individuals admitted to the Hospital Santa Casa de Londrina (HSCL) with programming for cardiac surgery with cardiopulmonary bypass, age above 18 years; and referral for surgery by the study teams. Individuals must be aware, informed, and agreed to participate in the study, including signing of SIC.
- Exclusion Criteria a. Individuals with cognitive impairment that prevents the implementation of spirometry (lung function ), manovacuometry (MIP and MEP) and incentive spirometry, below 18 years of age, patients with chronic obstructive pulmonary disease diagnosed by clinical history and spirometry ( FVC < 80 % predicted and / or FEV1 < 70 % predicted ) and individuals with a history of asthma. b . Patients will be withdrawn from the study and the Intention to Treat Analysis will be performed in the case of: patients who cannot be extubated because of the need for continuing mechanical ventilation after 24 hours of post-operative complications in the postoperative period; hemodynamic instability ; myocardial infarction during operation ; severe blood loss defined by the medical staff; loss of 20 % or more of total blood volume ( 12 ); mean arterial pressure (MAP ) < 70 mmHg,; reduced cardiac output requiring the use of intra-aortic balloon or vasoactive drugs for more than 72 hours, after ICU admission or need for new reintubation. Patients who did not agree to participate by not signing the SIC.
- Procedures and interventions a. randomization a.1 . After being selected by the inclusion criteria and had signed the informed consent preoperatively, patients will be allocated to one of two groups based on Consort ; a.2 . The allocation will be generated through a standardized random table. The allocation concealment will be ensured using opaque envelopes, sealed, and numbered serially. The envelope containing a card with the treatment will be opened by a secretary responsible for that.
- Formation of groups a. EI Group I - Intervention with flow-oriented incentive spirometry (IS) ( Trifllo ® - II ). b . BS Group II - Intervention with Breath- Stacking technique (BS).
- Recording and evaluation of the patient: patients included in the study will be recorded and evaluated by a physical therapist involved in the trial (blind) according to the standardized forms.
- Duration of the intervention: Both therapy modalities (Group I and Group II) will be held twice daily during the ICU stay, and once a day during hospitalization in the ward, until the fifth postoperative day. Each session will consist of three sets of five maneuvers.
- Conditions
- Postoperative Complications
- Being tested
- Incentive spirometry (IS), Breath Stacking (BS)
- Keywords
- Cardiac surgery, Spirometry, Physical Therapy Modalities, Postoperative Complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive spirometry (IS)Device
Mechanical devices activated by an inspiratory effort, which is viewed by the elevation of a plateau or balls in a transparent cylinder having a calibrated scale that displays the inspired flow.
Breath Stacking (BS)Device
Equipment with a one-way valve that masks and promotes the accumulation of successive inspiratory volumes, preventing expiration
| Study group | Role | What they receive |
|---|---|---|
| Incentive spirometry (IS) | Experimental | Group I Receives: Device: Incentive spirometry (IS) |
| Breath stacking (BS) | Active comparator | Group II Receives: Device: Breath Stacking (BS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary complications
- Pneumonia
- Atelectasis
- Acute respiratory infection
Measured: 18 months
Secondary outcomes (2)
Lung Function
Lung function will be assessed by spirometry, aimed at measuring the forced vital capacity (FVC), forced expiratory volume in one second (VFE1), and the ratio CVF/VFE1
Measured: 18 months
Respiratory muscle strength
Respiratory muscle strength will be assessed by measuring both the maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP). The values obtained for each volunteer on the respective predicted values for the Brazilian population, according to the prediction equations proposed by Neder et al will be compared.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2013
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliane Regina Ferreira Sernache de Freitas, Federal University of São Paulo
- Investigators
- Eliane Freitas, PhD, Principal investigator, Federal University of São Paulo and University of Northern Parana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054039
- Sponsor's protocol ID
- 186.780
- Status last verified
- Feb 2014
- First submitted
- 1 Feb 2014
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Incentive Spirometry and Breath Stacking After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02054039
- Acronym / sponsor ID
- 186.780
- Conditions
- Postoperative Complications
- Keywords
- Cardiac surgery, Spirometry, Physical Therapy Modalities, Postoperative Complications
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Feb 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.
- Postoperative pulmonary complications in patients undergoing cardiac surgery are a major clinical problem, presenting negative impact on morbidity, mortality , length of hospital stay and health care costs. Although physical therapy has been widely used as a resource to improve lung function in the postoperative period, the adoption of routine procedures of physical therapy needs be discussed.
- Incentive spirometers are mechanical devices used to reduce postoperative pulmonary complications. In general, they are activated by an inspiratory effort, visualized by an uplifted plate or ball in a transparent cylinder during sustained inspiration.
- Breath Stacking is a technique allowing the patient inhale a greater volume of air, kept for a longer period of time using a one-way valve, thus promoting the accumulation of successive inspiratory volume and preventing exhalation.
- The objective of the study is to evaluate the effectiveness of two different techniques of respiratory therapy on both reducing postoperative pulmonary complications and improving lung function.
- Type of study : randomized clinical trial
- Hypothesis
- Both techniques Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) and Breath Stacking ( BS ) may present similar effectiveness on reducing pulmonary complications, improving lung function and respiratory muscle strength ( MIP and MEP), as well as reducing hospital stay .
- Trifllo II Incentive Spirometry ( IS) (Trifllo ® - II ) may be more effective than Breath Stacking on reducing pulmonary complications, improving lung function and respiratory muscle strength, as well as reducing hospital stay.
Detailed description
- Type of study : randomized clinical trial
- Study site: The study will be carried out at the Hospital Santa Casa de Londrina.
- Subjects: all patients scheduled for cardiac surgery will be studied ( CABG and / or valve replacement )
- Patients will be evaluated both preoperatively, and on the fifth postoperative day (POD). They will be informed about the procedures to which they will be submitted, as well as the objective of the proposed study preoperatively. If approved by the patient, the "Statement of Informed Consent - SIC" will be signed.
- Inclusion Criteria
- Individuals admitted to the Hospital Santa Casa de Londrina (HSCL) with programming for cardiac surgery with cardiopulmonary bypass, age above 18 years; and referral for surgery by the study teams. Individuals must be aware, informed, and agreed to participate in the study, including signing of SIC.
- Exclusion Criteria a. Individuals with cognitive impairment that prevents the implementation of spirometry (lung function ), manovacuometry (MIP and MEP) and incentive spirometry, below 18 years of age, patients with chronic obstructive pulmonary disease diagnosed by clinical history and spirometry ( FVC < 80 % predicted and / or FEV1 < 70 % predicted ) and individuals with a history of asthma. b . Patients will be withdrawn from the study and the Intention to Treat Analysis will be performed in the case of: patients who cannot be extubated because of the need for continuing mechanical ventilation after 24 hours of post-operative complications in the postoperative period; hemodynamic instability ; myocardial infarction during operation ; severe blood loss defined by the medical staff; loss of 20 % or more of total blood volume ( 12 ); mean arterial pressure (MAP ) < 70 mmHg,; reduced cardiac output requiring the use of intra-aortic balloon or vasoactive drugs for more than 72 hours, after ICU admission or need for new reintubation. Patients who did not agree to participate by not signing the SIC.
- Procedures and interventions a. randomization a.1 . After being selected by the inclusion criteria and had signed the informed consent preoperatively, patients will be allocated to one of two groups based on Consort ; a.2 . The allocation will be generated through a standardized random table. The allocation concealment will be ensured using opaque envelopes, sealed, and numbered serially. The envelope containing a card with the treatment will be opened by a secretary responsible for that.
- Formation of groups a. EI Group I - Intervention with flow-oriented incentive spirometry (IS) ( Trifllo ® - II ). b . BS Group II - Intervention with Breath- Stacking technique (BS).
- Recording and evaluation of the patient: patients included in the study will be recorded and evaluated by a physical therapist involved in the trial (blind) according to the standardized forms.
- Duration of the intervention: Both therapy modalities (Group I and Group II) will be held twice daily during the ICU stay, and once a day during hospitalization in the ward, until the fifth postoperative day. Each session will consist of three sets of five maneuvers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive spirometry (IS) | Experimental | Device: Incentive spirometry (IS)Group I |
| Breath stacking (BS) | Active comparator | Device: Breath Stacking (BS)Group II |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects admitted to the Hospital Santa Casa de Londrina (HSCL) with programming for cardiac surgery with cardiopulmonary bypass, age above 18 years, and referral for surgery by the study teams. Individuals must be aware, informed, and agreed to participate in the study, including signing of SIC
Key exclusion criteria (2 listed)
- Individuals with cognitive impairment that prevents the implementation of spirometry (lung function ), manovacuometry (MIP and MEP) and incentive spirometry; below 18 years of age; patients with chronic obstructive pulmonary disease diagnosed by clinical history and spirometry ( FVC < 80 % of predicted and / or FEV1 < 70 % predicted); and individuals with a history of asthma.
- Patients will be withdrawn from the study and the Intention to Treat Analysis will be performed in the case of: patients who cannot be extubated because of the need for continuing mechanical ventilation after 24 hours of post-operative complications in the postoperative period; hemodynamic instability ; myocardial infarction during operation ; severe blood loss defined by the medical staff; loss of 20 % or more of total blood volume; mean arterial pressure (MAP ) < 70 mmHg; reduced cardiac output requiring the use of intra-aortic balloon or vasoactive drugs for more than 72 hours, after ICU admission or need for new reintubation. Patients who did not agree to participate by not signing the SIC
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 spirometry (IS)Mechanical devices activated by an inspiratory effort, which is viewed by the elevation of a plateau or balls in a transparent cylinder having a calibrated scale that displays the inspired flow. | Device | Incentive spirometry (IS) |
| Breath Stacking (BS)Equipment with a one-way valve that masks and promotes the accumulation of successive inspiratory volumes, preventing expiration | Device | Breath stacking (BS) |
Primary outcome
Pulmonary complications
Time frame: 18 months
* Pneumonia * Atelectasis * Acute respiratory infection
2 secondary outcomes
Lung Function
Time frame: 18 months
Respiratory muscle strength
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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.
Eliane Freitas, PhD principal investigator
Federal University of São Paulo and University of Northern Parana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Incentive spirometry (IS) and Breath Stacking (BS) in people with Postoperative Complications, run by Federal University of São Paulo at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 25 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eliane Freitas, PhD (55+ 43 99951354, elianefe@sercomtel.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary complications (time frame: 18 months). 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 25 Feb 2014; AzTrials last refreshed its copy on 28 Oct 2026.