Effect of Powerbreath Medic Plus versus Threshold IMT on maximal inspiratory pressure and functional capacity in post-operative ventricular septal defect closure: A protocol for a randomized controlled trial

Abstract

Background: Congenital heart disease is a general phrase that refers to any heart conditions that exist at birth, the most prevalent of which being ventricular septal defects (VSD) and foetal congenital malformations. VSD refers to the presence of aperture between the ventricles which leads to mixing of oxygenated and de-oxygenated blood. Although many VSDs close on their own, failing to do so can result in a number of issues and typically necessitates open heart surgery for closure of the defect. According to various studies, there is reduced functioning of diaphragm post cardiac surgeries which leads to occurrences of pulmonary complications such as lung collapse, fluid accumulation in pleura, pneumonia, acute respiratory distress syndrome and pneumothorax which can be debilitating and jeopardize recovery as well as increase hospital stay. There are several devices which are proven to improve the strength of inspiratory musculature and hence improve maximal inspiratory pressure and functional capacity post cardiac surgeries. Method: In this study we aimed to assess and evaluate the effectiveness of Powerbreath Medic Plus and Threshold Inspiratory Muscle Trainer (IMT) adjunct to conservative physiotherapy management on subjects who underwent VSD closure in a two arm parallel superiority randomized control trial on improving maximal inspiratory pressure and functional capacity. 60 individuals in total will be allocated equally into two groups, and both groups will be receiving treatment for four weeks with five sessions per week. After four weeks of therapy and two weeks after the intervention is through, the results will be assessed for follow-up. Predicted results: By increasing maximal inspiratory pressure and functional capacity, this technique may be used to treat complications following heart surgery if our study's premise is found to be significant. CTRI registration: CTRI/2023/03/051090