Complication, PostoperativeNCT04013360
Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery
A study testing Breath Stacking and Expiratory Positive Airway Pressure in people with Complication, Postoperative and Cardiac Complication, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
This study evaluates the efficacy and safety of a single session of positive expiratory pressure and of breath stacking technique in patients after cardiac surgery. The same patients will receive the two interventions, with an interval of 24 hours, and the acute effect of each will be verifed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complication, Postoperative, Cardiac Complication
- What is being tested?
- Breath Stacking and Expiratory Positive Airway Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2019to 4 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with indication for coronary artery bypass grafting and valve replacement, with surgical procedure for median sternotomy.
Who cannot join
- incapacity to understand the Informed Consent Form.
- cognitive dysfunction that prevents the performance of evaluations or interventions,
- intolerance to the use of EPAP or BS mask
- with chronic obstructive pulmonary disease (COPD)
- cerebrovascular disease
- chronic-degenerative musculoskeletal disease
Show all 12Show fewer
- chronic infectious disease
- in treatment with steroids, hormones or cancer chemotherapy
- hemodynamic complications (arrhythmia, myocardial infarction during the operation, with blood loss ≥ 20% of the total blood volume, defined by Mannuci, et al., 2007)
- mean arterial pressure <70 mmHg and reduced cardiac output, requiring the use of intra aortic balloon or vasoactive drugs
- tracheal intubation for more than 12 hours after admission to the ICU or reintubated
- individuals unable to maintain airway permeability.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Santa Maria
Santa Maria, Rio Grande do Sul, 97105-900
About this study
Official title: Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery: a Randomized Crossover Trial
This study evaluates the efficacy and safety of a single session of positive expiratory pressure and of breath stacking technique in patients after cardiac surgery. The same patients will receive the two interventions, with an interval of 24 hours, and the acute effect of each will be verifed.
Read the detailed description
Physiotherapy uses techniques and equipment that reduce postoperative pulmonary complications. The technique called breath stacking consists of an instrumental feature composed of a unidirectional valve coupled to a face mask to promote the accumulation of successive inspiratory volumes. The technique is used to prevent atelectasis and improve gas exchange. Another therapy is called expiratory positive airway pressure (EPAP) that uses positive end expiratory pressure (PEEP) in spontaneously breathing patients, keeping the airway open during expiration. The EPAP system consists of a face mask, a one-way valve and the expiratory resistor, which is responsible for resistance to expiratory flow, which will determine the level of PEEP.
- Conditions
- Complication, Postoperative, Cardiac Complication
- Being tested
- Breath Stacking, Expiratory Positive Airway Pressure
- Keywords
- Cardiac Surgery, Positive End Expiratory Pressure, Physical Therapy Techniques, Pulmonary Funtcion
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath StackingOther
The patients will perform the maneuver through successive inspiratory efforts for 20 s. Subsequently, the expiratory branch will be unobstructed to allow expiration. This maneuver will be repeated 5 times in each series, with intervals of 30 seconds between them. The technique will be performed with the trunk inclined 30º in relation to the horizontal plane, in 3 series, with interval of 2 min completing 15 min of therapy.
Expiratory Positive Airway PressureOther
Patients will perform exhalation of air through a facial mask containing an extrinsic positive expiratory pressure valve with a defined load of 10 cmH2O for 5 min. During the application of the technique the patients will have a trunk inclined 30º and will be stimulated to breathe normally, without effort or deep and fast breaths.
| Study group | Role | What they receive |
|---|---|---|
| Breath Stacking | Active comparator | Instrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes. Receives: Other: Breath Stacking; Other: Expiratory Positive Airway Pressure |
| Expiratory Positive Airway Pressure | Active comparator | Therapeutic technique consisting of a face mask, a one-way valve and an expiratory resistor, responsible for resistance to expiratory flow, which will determine the level of pressure in the airway. Receives: Other: Breath Stacking; Other: Expiratory Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period. This measurement will be obtained through the the division of the minute volume by the respiratory rate.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Forced vital capacity (FVC)
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability <5%) and considered the best curve for the study.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Secondary outcomes (13)
Forced expiratory volume in the first second (FEV1)
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability <5%) and considered the best curve for the study.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Peak expiratory flow (PEF)
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability <5%) and considered the best curve for the study.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability <5%) and considered the best curve for the study.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Minute volume
It will be evaluated preoperatively and also before and after 10 minutes of each intervention. To obtain the Minute Volume (MV), the patient will be instructed to inhale and exhale slowly for one minute and the value of MV and respiratory rate (RR) will be recorded. The respiratory rate was measured by the movements of the rib cage during respiratory cycles performed in one minute. The MV will be obtained by a Wright ® ventilometer (British Oxigen Company, London, England).
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Respiratory rate
They will be assessed at baseline, immediately after and 10 minutes after each intervention. The respiratory rate was measured by the movements of the rib cage during respiratory cycles performed in one minute.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Heart rate
They will be assessed at baseline, immediately after and 10 minutes after each intervention, through multi-parameter monitor.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Peripheral Oxygen Saturation (SpO2)
They will be assessed at baseline, immediately after and 10 minutes after each intervention through the G-Tech® portable pulse oximeter.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Blood pressure
They will be assessed at baseline, immediately after and 10 minutes after each intervention. The blood pressure will be obtained through multi-parameter monitor.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Heart work measurement
They will be assessed at baseline, immediately after and 10 minutes after each intervention through the calculation of the double product (multiplication of systolic blood pressure by heart rate).
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Thoracoabdominal mobility
Will be evaluated by thoracic and abdominal cirtometry
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Painful perception in the surgical incision
Will be assessed at baseline, immediately after and 10 minutes after each intervention through a Visual Analog Scale, a one-dimensional instrument for evaluation of pain intensity, with a range of 1 to 10.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Degree of dyspnea
Will be assessed at baseline, immediately after and 10 minutes after each intervention, through the Modified Borg Scale, a vertical scale quantified from 0 to 10. Zero represents no symptoms and 10 represents maximum symptoms.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)
They will be assessed at baseline, immediately after and 10 minutes after each intervention, through clinical inspection.
Measured: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Aug 2019
- Primary completion30 Dec 2019
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication, PostoperativeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Antônio Marcos Vargas da Silva, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013360
- Sponsor's protocol ID
- 92331518.6.0000.5346
- Status last verified
- Apr 2020
- First submitted
- 2 Jul 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Positive Expiratory Pressure Versus Breath Stacking Technique After Cardiac Surgery: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT04013360
- Acronym / sponsor ID
- 92331518.6.0000.5346
- Conditions
- Complication, Postoperative, Cardiac Complication
- Keywords
- Cardiac Surgery, Positive End Expiratory Pressure, Physical Therapy Techniques, Pulmonary Funtcion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 9 Jul 2019 (actual)
- 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 study evaluates the efficacy and safety of a single session of positive expiratory pressure and of breath stacking technique in patients after cardiac surgery. The same patients will receive the two interventions, with an interval of 24 hours, and the acute effect of each will be verifed.
Detailed description
Physiotherapy uses techniques and equipment that reduce postoperative pulmonary complications. The technique called breath stacking consists of an instrumental feature composed of a unidirectional valve coupled to a face mask to promote the accumulation of successive inspiratory volumes. The technique is used to prevent atelectasis and improve gas exchange. Another therapy is called expiratory positive airway pressure (EPAP) that uses positive end expiratory pressure (PEEP) in spontaneously breathing patients, keeping the airway open during expiration. The EPAP system consists of a face mask, a one-way valve and the expiratory resistor, which is responsible for resistance to expiratory flow, which will determine the level of PEEP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breath Stacking | Active comparator | Other: Breath Stacking, Other: Expiratory Positive Airway PressureInstrument composed of a one-way valve coupled to a face mask to promote the accumulation of successive inspiratory volumes. |
| Expiratory Positive Airway Pressure | Active comparator | Other: Breath Stacking, Other: Expiratory Positive Airway PressureTherapeutic technique consisting of a face mask, a one-way valve and an expiratory resistor, responsible for resistance to expiratory flow, which will determine the level of pressure in the airway. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with indication for coronary artery bypass grafting and valve replacement, with surgical procedure for median sternotomy.
Key exclusion criteria (12 listed)
- incapacity to understand the Informed Consent Form.
- cognitive dysfunction that prevents the performance of evaluations or interventions,
- intolerance to the use of EPAP or BS mask
- with chronic obstructive pulmonary disease (COPD)
- cerebrovascular disease
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 |
|---|---|---|
| Breath StackingThe patients will perform the maneuver through successive inspiratory efforts for 20 s. Subsequently, the expiratory branch will be unobstructed to allow expiration. This maneuver will be repeated 5 times in each series, with intervals of 30 seconds between them. The technique will be performed with the trunk inclined 30º in relation to the horizontal plane, in 3 series, with interval of 2 min completing 15 min of therapy. | Other | Breath Stacking, Expiratory Positive Airway Pressure |
| Expiratory Positive Airway PressurePatients will perform exhalation of air through a facial mask containing an extrinsic positive expiratory pressure valve with a defined load of 10 cmH2O for 5 min. During the application of the technique the patients will have a trunk inclined 30º and will be stimulated to breathe normally, without effort or deep and fast breaths. | Other | Breath Stacking, Expiratory Positive Airway Pressure |
Primary outcome
Tidal volume
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period. This measurement will be obtained through the the division of the minute volume by the respiratory rate.
Forced vital capacity (FVC)
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
It will be evaluated preoperatively and also before and after 10 minutes of each intervention, in the postoperative period, as recommended by the American Thoracic Society and European Respiratory Society (2006) and based on reproducibility and acceptability criteria, three maneuvers will be performed (variability <5%) and considered the best curve for the study.
13 secondary outcomes
Forced expiratory volume in the first second (FEV1)
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Peak expiratory flow (PEF)
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Forced expiratory flow between 25 and 75% of the curve of FVC (FEF25-75)
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Minute volume
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Respiratory rate
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Heart rate
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Peripheral Oxygen Saturation (SpO2)
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Blood pressure
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Heart work measurement
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Thoracoabdominal mobility
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Painful perception in the surgical incision
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Degree of dyspnea
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
Signs of respiratory discomfort (dizziness, tachypnea, sweating, use accessory musculature)
Time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention
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 9 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breath Stacking and Expiratory Positive Airway Pressure in people with Complication, Postoperative and Cardiac Complication, run by Universidade Federal de Santa Maria 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 12 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 9 Apr 2020. 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.
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?
Tidal volume (time frame: 12 to 24 hours after removal of drains and 24 hours after primary intervention). The study lists 2 primary outcomes in all. 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 9 Apr 2020.