Trial document




This trial has been registered retrospectively.
drksid header

  DRKS00000449

Trial Description

start of 1:1-Block title

Title

Oxygenation during noninvasive ventilation: active valve- versus leak-circuit

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The current study investigates the impact of different ventilatory circuits in home mechanical noninvasive ventialtion. Here, differences could be expected by different expiratory valves and the impact of leaks during ventilation.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The current study investigates the impact of different ventilatory circuits in home mechanical noninvasive ventialtion. Here, differences of oxygen fraction (FiO2) of the inhaled air are firstly analyzed in different ventilatory circuits. Secondly adding artificial leaks close to the face mask. Ventilator settings and supplemental oxygen flow are not changed analyzing the different study settups. Measurements are performed at daytime noninvasive ventilation in awake patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000449
  •   2010/10/05
  •   2010/10/05
  •   yes
  •   Approved
  •   319/09, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   UKF002101  (Register klinischer Studien des Universitätsklinikums Freiburg)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J96.1 -  Chronic respiratory failure
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   active valve circuit with and without an artficial leak
  •   leak circuit with and without an artficial leak
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Crossover
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Difference of FiO2 at FiO2-sensor 2 (at the interface) between active valve circuit and leak circuit

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Mean transcutaneous PCO2, oxygen saturation (SaO2), Subjective ventilation quality

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2009/12/11
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients with stable hypercapnic chronic respiratory failure (CRF) on NPPV with supplemental oxygen of at least 2 L/min will be enrolled. Patients are referred to the Department of Pneumology of the University Hospital Freiburg for a routine control visit of their NPPV.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients who presented with an acute exacerbation (respiratory frequency 30 breaths/min, pH <7.35 or clinical signs of infection), those planned for weaning from invasive ventilation or those who had been intubated or tracheostomised during the previous 3 months will be excluded.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg, Abteilung Innere Medizin V - Pneumologie
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinik Freiburg Innere Medizin V - Pneumologie
    • Mr.  Dr.  Jan Hendrik  Storre 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinik Freiburg Innere Medizin V - Pneumologie
    • Mr.  Dr.  Jan Hendrik  Storre 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg, Abteilung Innere Medizin V - Pneumologie
    • Mr.  Prof. Dr.  Wolfram  Windisch 
    • Killianstr. 5
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2010/08/05
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.