Inspiratory Muscle Training During Right-heart Catheterization
Primary Purpose
Right-heart Hemodynamics, Respiratory Muscle Training, Inspiratory Resistance
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
RHC and IMT
Sponsored by
About this trial
This is an interventional basic science trial for Right-heart Hemodynamics focused on measuring right-heart catheterization, respiratory muscle training, inspiratory resistance, hemodynamics
Eligibility Criteria
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
Sites / Locations
- Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RHC and IMT
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Pulmonary Capillary Wedge Pressure
Change in Cardiac output
Change in Cardiac index
Change in Stroke volume index
Change in Stroke volume
Full Information
NCT ID
NCT02054728
First Posted
December 20, 2012
Last Updated
October 26, 2018
Sponsor
Wissenschaftliches Institut Bethanien e.V
1. Study Identification
Unique Protocol Identification Number
NCT02054728
Brief Title
Inspiratory Muscle Training During Right-heart Catheterization
Official Title
Inspiratory Muscle Training During Right-heart Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 16, 2012 (Actual)
Primary Completion Date
December 1, 2014 (Actual)
Study Completion Date
December 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wissenschaftliches Institut Bethanien e.V
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess hemodynamic effects of inspiratory muscle training during routinely performed right-heart catheterization.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right-heart Hemodynamics, Respiratory Muscle Training, Inspiratory Resistance
Keywords
right-heart catheterization, respiratory muscle training, inspiratory resistance, hemodynamics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RHC and IMT
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
RHC and IMT
Intervention Description
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 Outcome Measure Information:
Title
Change in Pulmonary arterial pressure
Description
Pulmonary arterial pressure will be measured during RHC with and without parallel Inspiratory Muscle Training (IMT). Changes related to IMT will be assessed.
Time Frame
During RHC with and without parallel IMT
Secondary Outcome Measure Information:
Title
Change in Pulmonary Capillary Wedge Pressure
Time Frame
During RHC with and without parallel IMT
Title
Change in Cardiac output
Time Frame
During RHC with and without parallel IMT
Title
Change in Cardiac index
Time Frame
During RHC with and without parallel IMT
Title
Change in Stroke volume index
Time Frame
During RHC with and without parallel IMT
Title
Change in Stroke volume
Time Frame
During RHC with and without parallel IMT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep and Respiratory Medicine
City
Solingen
State/Province
NRW
ZIP/Postal Code
42699
Country
Germany
12. IPD Sharing Statement
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Inspiratory Muscle Training During Right-heart Catheterization
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