CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Triburter +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05496049
NCT05496049N/ACompleted

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

Fundación Cardiovascular de Colombia·interventional·Posted Aug 10, 2022·Updated Dec 3, 2024

In Brief

A clinical study evaluating Triburter and Incentive spirometry for Thoracic Surgery and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesColombia
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedAug 10, 2022
Enrollment StartAug 1, 2022
Primary CompletionDec 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 3.9 years ago

Interventions

Triburterdevice

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.