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

November 28, 2024 updated by: Fundación Cardiovascular de Colombia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Santander
      • Piedecuesta, Santander, Colombia
        • Cardiac Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triburter
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
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
Active Comparator: Incentive spirometry
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0, day 14 and day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 and day 30

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 and day 30
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.
Day 0 and day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Cardiovascular de Colombia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 23, 2023

Study Completion (Actual)

December 23, 2023

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI-2022-04334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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