Trial document
DRKS00003447
Trial Description
Title
Activation of respiratory muscles during weaning from mechanical ventilation
Trial Acronym
wEanMG
URL of the Trial
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Brief Summary in Lay Language
Mechanical ventilation is often required in severe disease. The process of withdrawal of mechanical ventilation and establishment of breathing without ventilatory support is called „weaning“.
In long-term mechanical ventilation a tracheostomy is commonly performed. In long-term ventilation, respiratory muscles become less efficient and loose strength. Training of these weak respiratory muscles is the main aspect during weaning. However, overstressing these muscles in weaning is contraproductive and must be avoided.
Several previous studies have shown that different ventilator settings, body posture or spontaneous breathing may induce an elevated load on the respiratory muscles.
It is the aim of this study to assess the activation of the respiratory muscles during spontaneous breathing in different body postures. Surface electromyography is a noninvasive technique for assessing the electrical potential elicited by muscular action and allows objective measures of muscular function.
Brief Summary in Scientific Language
The main goal of the study is to express the effects of different body position (flat in bed, 30° elevated torso, sitting in bed) onto the respiratory muscles during spontaneous breathing trials. Furthermore, muscle activation during invasive ventilation and decanulation are to be assessed.
Parasternal muscles, the diaphragm and exspiratory muscles (M. rectus abdominis) will be measured using surface electromyography (EMG). Surface EMG is a noninvasive, painless and reproducible method of assessing muscular activation. EMG parameters will be correlated with physiological paramaters, such as breathing frequency, tidal volume, minute ventilation, oxygen saturation, heart rate and blood pressure.
The different body positions will be applied in randomized order.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00003447
- 2012/01/18
- [---]*
- yes
- Approved
- 447/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Secondary IDs
- U1111-1126-5775
Health Condition or Problem studied
- J96.99 - [generalization J96.9: Respiratory failure, unspecified]
Interventions/Observational Groups
- Body position: flat in bed, spontaneous breathing trial
- Body position: 30° elevated torso, spontaneous breathing trial
- Body position: sitting in bed, spontaneous breathing trial
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control (effective treament of control group)
- Basic research/physiological study
- Parallel
- N/A
- N/A
Primary Outcome
Primary endpoint is the muscular activation in contrast to maximal voluntary activation in the distinct muscular groups in three different body positions (%max) (flat, 30° elevated torso, sitting in bed) as assessed by surface EMG of the respiratory muscles (parasternal, diaphragm, M. rectus abdominis)
Secondary Outcome
Secondary endpoints are differences in muscular activation with respect to maximal voluntary activation as assessed by surface EMG of the respiratory muscles between sitting with blocked tracheal canula and decanulation. Furthermore differences in muscular activation during mechanical ventilation with regard to body position and changes in minute ventilation during changing body positions.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2012/01/23
- 20
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Patients during prolonged weaning will be recruited at the time point when at least 30min of spontaneous breathing can be performed without cardiorespiratory deteriorations. Patients should be tracheotomized with canula size ID 7,5 / 8.
Exclusion Criteria
Exclusion criteria are neuromuscular diseases, acute infections, minimal cooperation, implanted electrical devices or orthopedic limitations for certain body positions as requested by the study design.
Addresses
-
start of 1:1-Block address primary-sponsor
- Uniklinik Freiburg
- Mr.
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Uniklinik Freiburg Abt. Pneumologie
- Mr. Dr. Stephan Walterspacher
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 004076127074070
- 004976127074070
- stephan.walterspacher at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Uniklinik Freiburg Abt. Pneumologie
- Mr. Dr. Stephan Walterspacher
- Killianstr. 5
- 79106 Freiburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 004076127074070
- 004976127074070
- stephan.walterspacher at uniklinik-freiburg.de
- http://www.uniklinik-freiburg.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.dfg.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up complete
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- 2016/05/23
- 9
- 9