Inspiratory Muscle Training During Right-heart Catheterization

Study Overview
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Brief Summary
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The purpose of this study is to assess hemodynamic effects of inspiratory muscle training during routinely performed right-heart catheterization.

Detailed Description
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During the last years, respiratory muscle training (RMT) in patients with impaired respiratory muscle function, e.g. in chronic obstructive pulmonary disease (COPD), is increasingly applied. RMT can be done by applying increased respiratory effort for several minutes via an apparatus providing an inspiratory stenosis. Threshold IMT® (Philips Respironics) for example is such a training device, which is in the market for several years now and which has been used to conduct studies applying RMT. For example, it has been shown that training with the Threshold IMT® in patients with COPD increases inspiratory muscle strength, endurance and functional capacity and ameliorates dyspnea and quality of life. Furthermore, patients suffering from cardiac illness can also be affected by respiratory muscle impairment, which can add to their cardiogenic dyspnea. RMT can help improve dyspnea and physical exercise capacity in those patients as well. To date, no studies have been performed addressing acute hemodynamic effects of inspiratory muscle training. However, this is of special interest: COPD as well as heart failure patients show an increased prevalence of pulmonary hypertension. In case of suspected pulmonary hypertension, patients usually are subjected to right-heart catheterization (RHC) to arrive at a definitive diagnosis and assess severity and etiology of potentially present pulmonary hypertension. RHC is also a sensitive method to exclude an intracardial shunt in COPD patients. In this study, patients who are routinely subjected to RHC for the above mentioned reasons will be instructed to do RMT using the Threshold IMT® during RHC. Two days in advance they will begin a guided training to get familiar with the Threshold IMT®. The device's inspiratory resistance can be set between 9 and 41 cm H2O. A single training session consists of 7 cycles with 2 min inspiratory training each, followed by a 1 min break (total duration 21 min). RMT will be conducted with 20-30% of individual inspiratory muscle strength, which will be measured beforehand. During the RHC procedure the patients will again conduct RMT as instructed while the suspected hemodynamic effects will be documented.

Official Title
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Inspiratory Muscle Training During Right-heart Catheterization

Conditions
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Right-heart Hemodynamics, Respiratory Muscle Training, Inspiratory Resistance

Intervention / Treatment
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* Other: RHC and IMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Indication for right-heart catheterization Informed Consent provided Exclusion Criteria: Age < 18 years Inability or contraindication to undergo right-heart catheterization Inability or contraindication to undergo respiratory muscle training as required per protocol Pregnancy, lactation Any medical, psychological or other condition restricting the patient's ability to provide informed consent Participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RHC and IMT<br> | Other: RHC and IMT<br>* Eligible patients subjected to RHC will be instructed on how to do RMT using the Threshold IMT® two days in advance. RMT will be conducted with 20-30% of individual inspiratory muscle strength, which will be measured beforehand. A single training session consists of 7 cycles with 2 min inspiratory training each, followed by a 1 min break (total duration 21 min). The actual intervention consists of inspiratory muscle training (IMT) during right-heart catheterization for at least 2 min or as long as is necessary to measure all specified parameters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulmonary arterial pressure | Pulmonary arterial pressure will be measured during RHC with and without parallel Inspiratory Muscle Training (IMT). Changes related to IMT will be assessed. | During RHC with and without parallel IMT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulmonary Capillary Wedge Pressure |  | During RHC with and without parallel IMT | 
| Change in Cardiac output |  | During RHC with and without parallel IMT | 
| Change in Cardiac index |  | During RHC with and without parallel IMT | 
| Change in Stroke volume index |  | During RHC with and without parallel IMT | 
| Change in Stroke volume |  | During RHC with and without parallel IMT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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right-heart catheterization, respiratory muscle training, inspiratory resistance, hemodynamics