Thoracic SurgeryNCT05496049
Efficacy of Triburter on Respiratory Muscle Function in Patients After CABG in Cardiac Rehabilitation Phase II
A study testing Triburter and Incentive spirometry in people with Thoracic Surgery and Postoperative Period, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
Trial summary
Post-surgery patients have muscle impairments, especially in the respiratory muscles, because the anesthesia, surgical incision, mechanical ventilation, pain, and prolonged postures, affect the mechanical condition of respiratory muscles. Those consequences produce a low exercise tolerance and low quality of life. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thoracic Surgery, Postoperative Period, Weakness, Muscle
- What is being tested?
- Triburter and Incentive spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteColombia
- Study dates
- 1 Aug 2022to 23 Dec 2023
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients after Coronary Artery Bypass Graft Surgery
- Older 18 years
- Patients that can able to carry out spirometry and volumen lung measures
- Nyha <2
- Patients in phase 2 of cardiac rehabilitation.
- Absent clinical deterioration
- Mechanical ventilation <24 hours after surgery
Who cannot join
- High risk
- Pneumothorax
- Currently in a clinical trial
- Active smokers
- Patients with COPD
- Major complications hospital period
Show all 16Show fewer
- Neurological diseases or orthopedic diseases
- Patients who can not be able to carry out the lung function measures.
- Patients with CPAP or BiPAP
- Unable to provide
- Informed consent
- Unstable angina
- Decompensated congestive heart failure.
- Cognitive disorder.
- Uncontrolled arrhythmias.
- Uncontrolled arterial hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Triburter on Respiratory Muscle Function in Patients With CABG Who Belong to Cardiac Rehabilitation Phase II Coronary Artery Bypass Graft
Post-surgery patients have muscle impairments, especially in the respiratory muscles, because the anesthesia, surgical incision, mechanical ventilation, pain, and prolonged postures, affect the mechanical condition of respiratory muscles. Those consequences produce a low exercise tolerance and low quality of life. These patients must go to cardiac rehabilitation to improve heart functions; however, these patients have a weakness in their respiratory muscles. Currently, there are many devices for respiratory muscle strength, although these devices are expensive, and they only have one circuit for training (inspiratory or expiratory). Triburter is a new device with two valves and positive pressure generation, this is a promising alternative because Triburter improves the mechanics of ventilation, increasing their functionality and quality of life. For this reason, the main hypothesis is that respiratory muscle training with Triburter improves the strength of inspiratory and expiratory muscles.
Read the detailed description
Aim and objectives: The aim of this study is to determine the efficacy of the Triburter device in comparison with usual therapy (incentive spirometer), as a therapeutic element in respiratory therapy on respiratory muscle function in patients with cardiovascular surgery who will join the second phase of the cardiac rehabilitation program of Fundación Cardiovascular de Colombia. And the specific objectives will be to evaluate the magnitude of change of maximal inspiratory pressure and maximal expiratory pressure, lung function (spirometry), functional capability (6MWT), quality of life (SF-36) and identify the adverse events related to the use of Triburter or incentive Methods design: The design of the pilot study is a randomized clinical trial, open with a control group.
Sample: Following the recommendations to elaborate a pilot trial with feasibility and precision, the recruitment will count 30 patients with no probabilistic sample (intentional sample) Data collection: Personal information forms and case report forms are prepared by principal research after a literature review about relevant variables to collect in the study. CRF included questions regarding socio-economic variables, hospitalized factors, body mass index, heart rate, respiratory rate, and temperature. Then the patients were evaluated in aspects of muscle strength, lung function, functional capacity, and quality of life. The informed consent was obtained from all the patients. The purpose of the study was explained to each patient.
Statistical analyses Firstly, descriptive variables will express in the median and standard deviation for the numeric variables, and for the categoric variables will express in absolute value and percent. A bivariate analysis will be used to determine differences in intergroup through t - Test o Chi-square or U Mann Whitney as appropriate for the type of distribution. The use of crosstabs and categorization of dependent variables to define corresponding patients (with improvement on measures applied) to difference to each group. Correlations will search between clinical variables, functionality, and quality of life through bivariate analysis (spearman) and multivariate (logistic regression) To measure the change induced by training in the functional variables. the researchers will use the analysis of the change of percent [(value pos intervention - value pre/value pre)*100]. To compare the quantitative variables in the two situations (pre-post) and the same group, researchers will use the test of t student for the pair data, and multilevel analysis adjusted by each patient and analyzed by each intervention.
- Conditions
- Thoracic Surgery, Postoperative Period, Weakness, Muscle
- Being tested
- Triburter, Incentive spirometry
- Keywords
- Triburter, Respiratory muscle strength, Postoperative patients, Coronary artery bypass graft surgery, Respiratory Therapy
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriburterDevice
Also called Triburter device
Patients will have to repeat 50 ventilations (start with 20 repetitions in the first week, 30 in the second, 40 in the four week, and 50 in the last week) five days per day for four weeks. And they have to fill a calendar to ensurance the intervention.
Incentive spirometryDevice
They will repeat 10 ventilations per 5 five times a day. Both interventions will be performed for 4 weeks. They have to fill a calendar to ensurance the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Triburter | Experimental | The intervention group will receive a triburter device for training, the patients will have to repeat 50 ventilations (start with 20 repetitions in the first week, 30 in the second, 40 in the four week, and 50 in the last week) five days per day. Receives: Device: Triburter |
| Incentive spirometry | Active comparator | For the control group (incentive spirometry) they will repeat 10 ventilations per 5 five times a day. Both interventions will be performed for 4 weeks. Receives: Device: Incentive spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory muscles strength
The maximal inspiratory pressure (cmH2O) and maximal expiratory pressure (cmH2O) allow measure the strength of inspiratory and expiratory muscles. An increase in those pressures means an improvement on respiratory muscle strength
Measured: Day 0, day 14 and day 30
Secondary outcomes (1)
Change in the lung function
The lung function will measure by spirometry, specifically the forced expiratory volume in the 1st (Liters) second and forced vital capacity (Liters). An increase in those volumes means an improvement in lung function and expiratory muscles.
Measured: Day 0 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Aug 2022
- Primary completion23 Dec 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Thoracic 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
- Model description
- Participants will be randomized into two groups by a randomization list provided by a computer program. The intervention group will receive a triburter device for training, the patients will have to repeat 50 ventilations (start with 20 repetitions in the first week, 30 in the second, 40 in the four week, and 50 in the last week) five days per day. For the control group (incentive spirometry) they will repeat 10 ventilations per 5 five times a day. Both interventions will be performed for 4 weeks.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Cardiovascular de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496049
- Sponsor's protocol ID
- CEI-2022-04334
- Status last verified
- Nov 2024
- First submitted
- 8 Aug 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siafakas NM, Mitrouska I, Bouros D, Georgopoulos D. Surgery and the respiratory muscles. Thorax. 1999 May;54(5):458-65. doi: 10.1136/thx.54.5.458. No abstract available.
PubMed 10212115Bergofsky EH. Respiratory failure in disorders of the thoracic cage. Am Rev Respir Dis. 1979 Apr;119(4):643-69. doi: 10.1164/arrd.1979.119.4.643. No abstract available.
PubMed 375788Sobush DC, Dunning M 3rd. Providing resistive breathing exercise to the inspiratory muscles using the PFLEX device. Suggestion from the field. Phys Ther. 1986 Apr;66(4):542-4. doi: 10.1093/ptj/66.4.542.
PubMed 3960983Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
PubMed 22008401Hermes BM, Cardoso DM, Gomes TJ, Santos TD, Vicente MS, Pereira SN, Barbosa VA, Albuquerque IM. Short-term inspiratory muscle training potentiates the benefits of aerobic and resistance training in patients undergoing CABG in phase II cardiac rehabilitation program. Rev Bras Cir Cardiovasc. 2015 Jul-Aug;30(4):474-81. doi: 10.5935/1678-9741.20150043.
PubMed 27163422Smith JR, Taylor BJ. Inspiratory muscle weakness in cardiovascular diseases: Implications for cardiac rehabilitation. Prog Cardiovasc Dis. 2022 Jan-Feb;70:49-57. doi: 10.1016/j.pcad.2021.10.002. Epub 2021 Oct 22.
PubMed 34688670Franklin E, Anjum F. Incentive Spirometer and Inspiratory Muscle Training. 2023 Apr 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572114/
PubMed 34283480
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Triburter on Respiratory Muscle Function in Patients With CABG Who Belong to Cardiac Rehabilitation Phase II Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT05496049
- Acronym / sponsor ID
- CEI-2022-04334
- Conditions
- Thoracic Surgery, Postoperative Period, Weakness, Muscle
- Keywords
- Triburter, Respiratory muscle strength, Postoperative patients, Coronary artery bypass graft surgery, Respiratory Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundación Cardiovascular de ColombiaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 10 Aug 2022 (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.
Post-surgery patients have muscle impairments, especially in the respiratory muscles, because the anesthesia, surgical incision, mechanical ventilation, pain, and prolonged postures, affect the mechanical condition of respiratory muscles. Those consequences produce a low exercise tolerance and low quality of life. These patients must go to cardiac rehabilitation to improve heart functions; however, these patients have a weakness in their respiratory muscles. Currently, there are many devices for respiratory muscle strength, although these devices are expensive, and they only have one circuit for training (inspiratory or expiratory). Triburter is a new device with two valves and positive pressure generation, this is a promising alternative because Triburter improves the mechanics of ventilation, increasing their functionality and quality of life. For this reason, the main hypothesis is that respiratory muscle training with Triburter improves the strength of inspiratory and expiratory muscles.
Detailed description
Aim and objectives: The aim of this study is to determine the efficacy of the Triburter device in comparison with usual therapy (incentive spirometer), as a therapeutic element in respiratory therapy on respiratory muscle function in patients with cardiovascular surgery who will join the second phase of the cardiac rehabilitation program of Fundación Cardiovascular de Colombia. And the specific objectives will be to evaluate the magnitude of change of maximal inspiratory pressure and maximal expiratory pressure, lung function (spirometry), functional capability (6MWT), quality of life (SF-36) and identify the adverse events related to the use of Triburter or incentive Methods design: The design of the pilot study is a randomized clinical trial, open with a control group.
Sample: Following the recommendations to elaborate a pilot trial with feasibility and precision, the recruitment will count 30 patients with no probabilistic sample (intentional sample) Data collection: Personal information forms and case report forms are prepared by principal research after a literature review about relevant variables to collect in the study. CRF included questions regarding socio-economic variables, hospitalized factors, body mass index, heart rate, respiratory rate, and temperature. Then the patients were evaluated in aspects of muscle strength, lung function, functional capacity, and quality of life. The informed consent was obtained from all the patients. The purpose of the study was explained to each patient.
Statistical analyses Firstly, descriptive variables will express in the median and standard deviation for the numeric variables, and for the categoric variables will express in absolute value and percent. A bivariate analysis will be used to determine differences in intergroup through t - Test o Chi-square or U Mann Whitney as appropriate for the type of distribution. The use of crosstabs and categorization of dependent variables to define corresponding patients (with improvement on measures applied) to difference to each group. Correlations will search between clinical variables, functionality, and quality of life through bivariate analysis (spearman) and multivariate (logistic regression) To measure the change induced by training in the functional variables. the researchers will use the analysis of the change of percent [(value pos intervention - value pre/value pre)*100]. To compare the quantitative variables in the two situations (pre-post) and the same group, researchers will use the test of t student for the pair data, and multilevel analysis adjusted by each patient and analyzed by each intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two groups by a randomization list provided by a computer program. The intervention group will receive a triburter device for training, the patients will have to repeat 50 ventilations (start with 20 repetitions in the first week, 30 in the second, 40 in the four week, and 50 in the last week) five days per day. For the control group (incentive spirometry) they will repeat 10 ventilations per 5 five times a day. Both interventions will be performed for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Triburter | Experimental | Device: TriburterThe intervention group will receive a triburter device for training, the patients will have to repeat 50 ventilations (start with 20 repetitions in the first week, 30 in the second, 40 in the four week, and 50 in the last week) five days per day. |
| Incentive spirometry | Active comparator | Device: Incentive spirometryFor the control group (incentive spirometry) they will repeat 10 ventilations per 5 five times a day. Both interventions will be performed for 4 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients after Coronary Artery Bypass Graft Surgery
- Older 18 years
- Patients that can able to carry out spirometry and volumen lung measures
- Nyha <2
- Patients in phase 2 of cardiac rehabilitation.
Key exclusion criteria (16 listed)
- High risk
- Pneumothorax
- Currently in a clinical trial
- Active smokers
- Patients with COPD
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 |
|---|---|---|
| TriburterAlso: Triburter devicePatients will have to repeat 50 ventilations (start with 20 repetitions in the first week, 30 in the second, 40 in the four week, and 50 in the last week) five days per day for four weeks. And they have to fill a calendar to ensurance the intervention. | Device | Triburter |
| Incentive spirometryThey will repeat 10 ventilations per 5 five times a day. Both interventions will be performed for 4 weeks. They have to fill a calendar to ensurance the intervention. | Device | Incentive spirometry |
Primary outcome
Change in respiratory muscles strength
Time frame: Day 0, day 14 and day 30
The maximal inspiratory pressure (cmH2O) and maximal expiratory pressure (cmH2O) allow measure the strength of inspiratory and expiratory muscles. An increase in those pressures means an improvement on respiratory muscle strength
1 secondary outcome
Change in the lung function
Time frame: Day 0 and day 30
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 3 Dec 2024.
- Results publication: PubMed 10212115Siafakas NM, Mitrouska I, Bouros D, Georgopoulos D. Surgery and the respiratory muscles. Thorax. 1999 May;54(5):458-65. doi: 10.1136/thx.54.5.458. No abstract available.
- Results publication: PubMed 375788Bergofsky EH. Respiratory failure in disorders of the thoracic cage. Am Rev Respir Dis. 1979 Apr;119(4):643-69. doi: 10.1164/arrd.1979.119.4.643. No abstract available.
- Results publication: PubMed 3960983Sobush DC, Dunning M 3rd. Providing resistive breathing exercise to the inspiratory muscles using the PFLEX device. Suggestion from the field. Phys Ther. 1986 Apr;66(4):542-4. doi: 10.1093/ptj/66.4.542.
- Results publication: PubMed 22008401Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
- Results publication: PubMed 27163422Hermes BM, Cardoso DM, Gomes TJ, Santos TD, Vicente MS, Pereira SN, Barbosa VA, Albuquerque IM. Short-term inspiratory muscle training potentiates the benefits of aerobic and resistance training in patients undergoing CABG in phase II cardiac rehabilitation program. Rev Bras Cir Cardiovasc. 2015 Jul-Aug;30(4):474-81. doi: 10.5935/1678-9741.20150043.
- Results publication: PubMed 34688670Smith JR, Taylor BJ. Inspiratory muscle weakness in cardiovascular diseases: Implications for cardiac rehabilitation. Prog Cardiovasc Dis. 2022 Jan-Feb;70:49-57. doi: 10.1016/j.pcad.2021.10.002. Epub 2021 Oct 22.
- Results publication: PubMed 34283480Franklin E, Anjum F. Incentive Spirometer and Inspiratory Muscle Training. 2023 Apr 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572114/
- Individual participant dataSharing planned: No
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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 Triburter and Incentive spirometry in people with Thoracic Surgery and Postoperative Period, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
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 7 inclusion and 16 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 3 Dec 2024. 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 Colombia. 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?
Change in respiratory muscles strength (time frame: Day 0, day 14 and day 30). 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 NCT05496049, which also lists 7 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 3 Dec 2024.