Trial document




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  DRKS00005639

Trial Description

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Title

Respiratory muscle activation in COPD during noninvasive mechanical ventilation

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Trial Acronym

HiLo NPPV

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Noninvasive ventilation (NIV) is established in treating patients with chronic hypercapnic respiratory failure due to chronic obstructive pulmonary disease (COPD).
In recent years different forms of NIV have been established. It remains unknown so far, which ventilation mode is best in unloading the respiratory muscles.
This study aims at assessing respiratory muscle unloading in three different settings of NIV by non-invasive surface electromyography of the respiratory muscles. Each ventilation session will be held for 30min.
This study aims at evaluating which mode of NIV is most favorable for respiratory muscle unloading. Study subjects will be recruited during their routine vivits in our respiratory department for checkup of the established NIV due to COPD.

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Brief Summary in Scientific Language

This study aims at assessing respiratory muscle activation during three different modes of noninvasive ventilation (NIV) in patients with chronic hypercapnic respiratory failure due to COPD and established NIV.
Respiratory muscle unloading will be assessed by noninvasive surface electromyography (EMG) of M. sternocleidomastoideus, parasternal muscles and the diaphragm during ventilation periods of 30min in each study mode. Prior and post each ventilation session lung function parameters will be assessed.

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Organizational Data

  •   DRKS00005639
  •   2014/02/06
  •   [---]*
  •   yes
  •   Approved
  •   37/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1152-0333 
  •   [---]* 
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Health Condition or Problem studied

  •   J44.89 -  [generalization J44.8: Other specified chronic obstructive pulmonary disease]
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Interventions/Observational Groups

  •   Following blood gas measurements and siprometry the patient will be put in a sitting position. Surface-EMG electrodes will be placed after desinfection and cleansing of the skin.
    Signal quality will be checked by performing maximal volunatry breathing maneuvers (PImax, Sniff, TLC-breathing).
    The different modes of NIV will be performed in a randomized order in a half-sitting position. Each ventilation mode will be performed for 30min; there will be 15min of rest between each study session. NIV will be performed with the NIV-masks for the individual therapy.
    Setting 1: low-intensity NIV - pressure settings will be set according to the previous study performed by our group.
  •   Setting 2: high-intensity NIV as established for chronic NIV with high backup breathing rate
  •   Setting 3: (established) high-intensity NIV with low backup breathing rate
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Differences in parasternal respiratory muscle activation applying electromyography during different modes of noninvasive mechanical ventilation with respect to maximal volitional respiratory muscle activation.

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Secondary Outcome

- resting EMG of the respiratory muscles (M. sternocleidomastoideus, parasternal muscles, diaphragm) for the right / left body side
- maximal innervation as assessed by EMG during maximal voluntary breathing maneuvers (PImax, Sniff, TLC-breathing)
- sensation of dysnpoea during different modes of noninvasive mechanical ventilation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2014/02/10
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with advanced stable hypercapnic COPD and established noninvasive mechanical ventilation

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Exclusion Criteria

- severe hypoxia ((PaO2 < 60mmHg despite oxygen supplementation)
- haemodynamic instability within the last 24h
- neuromuscular disease
- acute infectin (procalcitonin >10 ng/ml and/or CRP > 10 mg/dl)
- missing cooperation
- use of sedative or analgetic agents within the last 6h
- body mass index > 30 kg/m2

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Uniklinik Freiburg, Department für Innere Medizin, Klinik für Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg, Department für Innere Medizin, Klinik für Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg, Department für Innere Medizin, Klinik für Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg, Department für Innere Medizin, Klinik für Pneumologie
    • Mr.  Dr. med.  Stephan  Walterspacher 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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