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Completed

NCT Number: NCT05496049

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

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.

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Key information

Conditions

Thoracic Surgery Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Period Signs and Symptoms Weakness, Muscle

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiac Rehabilitation

Piedecuesta, Santander Department, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Triburter device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in the lung function

    Time frame: Day 0 and day 30

    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.

Other outcomes

  1. Change in the functional capacity

    Time frame: Day 0 and day 30

    The functional capacity is going to measure by six-minute walk test (meters walking) An increase in meters means an improvement in functionallity.

  2. Change in quality of life

    Time frame: Day 0 and day 30

    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.

Sponsors and collaborators

Lead sponsor

Fundación Cardiovascular de Colombia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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