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

Thoracic Surgery Clinical Trial

Official title:

Efficacy of Triburter on Respiratory Muscle Function in Patients With CABG Who Belong to Cardiac Rehabilitation Phase II Coronary Artery Bypass Graft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496049
• Other study ID #: CEI-2022-04334
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: January 23, 2023

Study information

• Verified date: September 2022
• Source: Fundación Cardiovascular de Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 23, 2023
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• Uncontrolled arterial hypertension

Related Conditions & MeSH terms

• Muscle Weakness
• Postoperative Period
• Thoracic Surgery
• Weakness, Muscle

Intervention

Device:
• Triburter
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 spirometry
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.

Locations

Country	Name	City	State
Colombia	Cardiac Rehabilitation	Piedecuesta	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Cardiovascular de Colombia

Country where clinical trial is conducted

Colombia, 

References & Publications (7)

Bergofsky EH. Respiratory failure in disorders of the thoracic cage. Am Rev Respir Dis. 1979 Apr;119(4):643-69. Review. — View Citation

Franklin E, Anjum F. Incentive Spirometer and Inspiratory Muscle Training. 2022 Jun 19. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572114/ — View Citation

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 rehabilitati — View Citation

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

Siafakas NM, Mitrouska I, Bouros D, Georgopoulos D. Surgery and the respiratory muscles. Thorax. 1999 May;54(5):458-65. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the functional capacity	The functional capacity is going to measure by six-minute walk test (meters walking) An increase in meters means an improvement in functionallity.	Day 0 and day 30
Other	Change in quality of life	The variable quality of life will assess with SF-36 (0-100) with its 6 components( physical function, physic role, body pain, general health, vitality, social function, emotional role and mental health. An increase in these values means an improvement in quality of life.	Day 0 and day 30
Primary	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	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.	Day 0 and day 30