Efficacy of Triburter on Respiratory Muscle Function in Patients After CABG in Cardiac Rehabilitation Phase II

NCT05496049 | Completed DMC

• 1 other identifier: CEI-2022-04334
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thoracic Surgery; Postoperative Period; Weakness, Muscle

Keywords

Triburter; Respiratory muscle strength; Postoperative patients; Coronary artery bypass graft surgery; Respiratory Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0, day 14 and day 30

Secondary Outcomes (1)

• Change in the lung function

  Day 0 and day 30

Other Outcomes (2)

• Change in the functional capacity

  Day 0 and day 30

• Change in quality of life

  Day 0 and day 30

Study Arms (2)

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.

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.

Device: Incentive spirometry

Interventions

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.

Also known as: Triburter device

Triburter

Incentive spirometry DEVICE

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.

Incentive spirometry

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• High risk
• Pneumothorax
• Currently in a clinical trial
• Active smokers
• Patients with COPD
• Major complications hospital period
• 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.

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead

Study Sites (1)

Cardiac Rehabilitation

Piedecuesta, Santander Department, Colombia

Location

Related Publications (7)

• 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.

  PMID: 10212115 BACKGROUND

• Bergofsky 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.

  PMID: 375788 BACKGROUND

• Sobush 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.

  PMID: 3960983 BACKGROUND

• Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.

  PMID: 22008401 BACKGROUND

• Hermes 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.

  PMID: 27163422 BACKGROUND

• Smith 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.

  PMID: 34688670 BACKGROUND

• Franklin E, Anjum F. Incentive Spirometer and Inspiratory Muscle Training. 2023 Apr 27. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572114/

  PMID: 34283480 BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: August 1, 2022
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)