Trial document

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DRKS-ID: DRKS00003447

Trial Description

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Title

Activation of respiratory muscles during weaning from mechanical ventilation

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Trial Acronym

wEanMG

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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.

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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.

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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

DRKS-ID: DRKS00003447
Date of Registration in DRKS: 2012/01/18
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 447/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

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Secondary IDs

Universal Trial Number (UTN): U1111-1126-5775

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Health Condition or Problem studied

ICD10: J96.99 - [generalization J96.9: Respiratory failure, unspecified]

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Interventions/Observational Groups

Arm 1: Body position: flat in bed, spontaneous breathing trial
Arm 2: Body position: 30° elevated torso, spontaneous breathing trial
Arm 3: Body position: sitting in bed, spontaneous breathing trial

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Active control (effective treament of control group)
Purpose: Basic research/physiological study
Assignment: Parallel
Phase: N/A
Off-label Drug use: N/A

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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)

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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.

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Countries of Recruitment

DE: Germany

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Locations of Recruitment

University Medical Center Pneumologie, Freiburg im Breisgau

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2012/01/23
Target Sample Size: 20
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

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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.

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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.

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Addresses

Primary Sponsor
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- Uniklinik Freiburg
- Mr.
- Killianstr. 5
- 79106 Freiburg
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.uniklinik-freiburg.de
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Contact for Scientific Queries
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- Uniklinik Freiburg Abt. Pneumologie
- Mr. Dr. Stephan Walterspacher
- Killianstr. 5
- 79106 Freiburg
- Germany
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- Telephone: 004076127074070
- Fax: 004976127074070
- E-mail: stephan.walterspacher at uniklinik-freiburg.de
- URL: http://www.uniklinik-freiburg.de
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Contact for Public Queries
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- Uniklinik Freiburg Abt. Pneumologie
- Mr. Dr. Stephan Walterspacher
- Killianstr. 5
- 79106 Freiburg
- Germany
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- Telephone: 004076127074070
- Fax: 004976127074070
- E-mail: stephan.walterspacher at uniklinik-freiburg.de
- URL: http://www.uniklinik-freiburg.de
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.dfg.de
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Status

Recruitment Status: Recruiting complete, follow-up complete
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): 2016/05/23
Number of Participants in Germany after Recruiting complete: 9
Total Number of Participants (all Sites worldwide) after Recruiting complete: 9

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Trial Publications, Results and other Documents

Paper: Link zur Publikation https://doi.org/10.1016/j.jcrc.2016.11.033

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* This entry means the parameter is not applicable or has not been set.