Skip to main content
OpenTrials
Completed

NCT Number: NCT02054728

Inspiratory Muscle Training During Right-heart Catheterization

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine

Solingen, North Rhine-Westphalia, 42699, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

RHC and IMT

Other

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.

Primary outcomes

  1. Change in Pulmonary arterial pressure

    Time frame: During RHC with and without parallel IMT

    Pulmonary arterial pressure will be measured during RHC with and without parallel Inspiratory Muscle Training (IMT). Changes related to IMT will be assessed.

Secondary outcomes

  1. Change in Pulmonary Capillary Wedge Pressure

    Time frame: During RHC with and without parallel IMT

  2. Change in Cardiac output

    Time frame: During RHC with and without parallel IMT

  3. Change in Cardiac index

    Time frame: During RHC with and without parallel IMT

  4. Change in Stroke volume index

    Time frame: During RHC with and without parallel IMT

  5. Change in Stroke volume

    Time frame: During RHC with and without parallel IMT

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2014
Registry last updated
Oct 30, 2018

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.

Published trials that share one or more normalized conditions with this study.