Trial document




drksid header

  DRKS00011041

Trial Description

start of 1:1-Block title

Title

Non-invasive ventilation as a therapy option of AECOPD in emergency medical services

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

Trial Acronym

NOVETO-Trial

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 chronical obstructive pulmonary disease (COPD) is characterized by a progressive deterioration in lung function and an increasing deterioration of health condition, performance and quality of life, especially caused by repeated acute exacerbations of lung function and increasing effects on other organs.

The treatment of acute exacerbated COPD includes, depending on the severity, a drug therapy, as well as sufficient enrichment of the blood with oxygen, either by the simple oxygen inhalation, a special non-invasive ventilation combined with a ventilator mask and the spontaneous breathing by the patient or in the worst case general anesthesia with artificial respiration.

Although non-invasive ventilation, as a treatment option for acutely exarcerbated COPD, is widely used in German emergency services, there is still no definite study data whether patients really benefit from a non-invasiv ventilation that is performed prior to hospitalization. That's why we will acquire data from patients with acutely exacerbated COPD which are treated by emergency doctors from Heidelberg and Walldorf and evaluate it. The acquisition period will be more than 18 months.

Three groups of patients will be compared:

1.) patients with conservative therapy, drug therapy combined with oxygen inhalation
2.) patients with drug treatment combined with a attempt of non-invasive ventilation
3.) patients with drug therapy combined with general anesthesia and artificial respiration, without a prior attempt of non-invasive ventilation.

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

Brief Summary in Scientific Language

Beside the regular therapy with drugs and oxygen, there is a special treament option also in the emergency medical Services available, the non invasive Ventilation (NIV) with a special face mask. The German S3 Guideline for the treatment of acute respiratory failure also recommends this therapy option.
For the Treatment, a special ventilator is also necessary that supports the patients respiratory work. At the end of the expiration a positive preasure (PEEP) is still in the lower airways that helps to open up closed lung areals, indcues a better oxygenation and reduces the patients respiratory work. Simultaneously common complications of an invasive ventilation therapy with a breathing tube could be avoided (e.g. pneumonia, intuibation injuries, prolonged weaning).

Although non-invasive ventilation, as a treatment option for acutely exarcerbated COPD, is widely used in German emergency services, but there is still no definite study data whether patients really benefit from a non-invasiv ventilation that is performed prior to hospitalization. That's why we will acquire data from patients with acutely exacerbated COPD which are treated by emergency doctors from Heidelberg and Walldorf and evaluate it. The acquisition period will be more than 18 months.

The design of the study is sheer descriptive and has no influence on the treatment of the patients. The enrollment in the three different study groups depends on the emergency doctors treatment and they are free in their decision. (There are no additional study associated treatments)

Three groups of patients will be compared:

1.) patients with conservative therapy, drug therapy combined with oxygen inhalation
2.) patients with drug treatment combined with a attempt of non-invasive ventilation
3.) patients with drug therapy combined with general anesthesia and artificial respiration, without a prior attempt of non-invasive ventilation.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011041
  •   2016/09/13
  •   [---]*
  •   yes
  •   Approved
  •   S-203/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J44.1 -  Chronic obstructive pulmonary disease with acute exacerbation, unspecified
  •   J96.0 -  Acute respiratory failure
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   1.) drug therapy (the emergency doctor decides indivdually the choice of drugs and dosage) combined with oxygen inhalation
  •   2.) drug therapy (the emergency doctor decides indivdually the choice of drugs and dosage) combined with a attempt of non-invasive ventilation
  •   3.) drug therapy (the emergency doctor decides indivdually the choice of drugs and dosage) combined with general anesthesia and artificial respiration, without a prior attempt of non-invasive ventilation.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prognosis
  •   Factorial
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Improvement of the oxygenation and decarboxylation at clinic Admission -> documentation of the SpO2 values at the beginning and at the end of the prehospital treatment. Documentation of the O2 and CO2 values at the Hospital admission

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

Secondary Outcome

Reduction of the treatment-period -> documentation at the discharge of the hospital stay: ventilation-period, length of the intensiv care therapy and hospital stay

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

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2016/10/01
  •   150
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

AECOPD and >18years

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

Exclusion Criteria

Non-fullfillment of the inclusion criteria

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für AnästhesiologieUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Stefan  Hofer 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • 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 other
    • Innere Medizin IIIUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Hugo A.  Katus 
    • Im Neuenheimer Feld 324
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • 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
    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • 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
    • Klinik für AnästhesiologieUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Stefan  Hofer 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • 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 planned
  •   [---]*
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.