Trial document




drksid header

  DRKS00013935

Trial Description

start of 1:1-Block title

Title

Determination of the diagnostic accuracy of capnovolumetry for the detection of airway obstruction

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

Capnovolumetry is a diagnostic device which allows to detect airway obstruction during tidal breathing, which is independent from the patients´ breathing efforts. The determination is based on the ultrasound based measurement of the CO2 flow (capnovolumetry). Capnovolumetry as an index test will be performed before routine investigation of the patient with whole body plethysmography as a reference standard.
Capnovolumetry has been integrated into the SpiroScout, a device primarily created for spirometry by the Ganshorn company. This for the first time offers the opportunity to have a device that allows to test the usefulness of capnovolumetry in clinical practice without significant additional investment and efforts. The objective of the study is to determine the diagnostic accuracy of capnovolumetry for the detection of airway obstruction.

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

Brief Summary in Scientific Language

Capnovolumetry is a diagnostic procedure which allows to detect airway obstruction during tidal breathing, independent from the patients´ breathing efforts. The measurement is realized with an ultrasound based measurement of the CO2 flow (capnovolumetry) and integrated into a spirometer.
Index test: Patients will be advised for tidal breathing through a tube of the SpiroScout spirometer. Five tidal breathing maneuvers are performed.
Reference standard: Patients will be investigated for diagnosis or routine follow-up in a large private practice of pneumologists with whole body plethysmography. Airway obstruction will be diagnosed by the pneumologists, if FEV1/FVC < LLN corresponding to a z-score of < -1.645 and / or increased specific airway resistance sRaw > 2.0 kPa*s are present, taking into account medical history and clinical findings. The pneumologists will be blinded against the results of capnovolumetry.
The diagnostic accuracy of capnovolumetry as index test will be determined by sensitivity, specificity, positive and nevative predictive value in comparison with bodyplethysmography as a reference standard (2 x 2 contingency table). According to power calculation, at least 1280 patients must be included to determine the sensitivity and specificity of 80% with a 95% confidence interval of +5%.

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

  •   DRKS00013935
  •   2018/03/01
  •   [---]*
  •   yes
  •   Approved
  •   522/17 S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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

  •   R94.2 -  Abnormal results of pulmonary function studies
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Adult patients coming for diagnostic investigation or routine follow-up into the private practice of pneumologists (centre for pneumonology, oncology and sleep medicine at the Diakonissenhaus in Augsburg). Patients will be included consecutively. Measurement of capnovolumetry will be performed before Investigation with bodyplethysmography. The pneumologist is blinded against the results of the bodyplethysmography.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary Outcome:
- specificity
- sensitivity
- positive and negative predictive value of the quotient of ascending slopes (SIII / SII) at a cut-off-value ≥ 0.10 for the detection of an existing airway obstruction
In comparison with bodyplethysmograpy results (indicating airway obstruction FEV1 < 70% of normal, pathological sRAW / RAW)

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

Secondary Outcome

Secondary outcome:
- sensitivity
- specificity and
- predictive values of other ascending slope quotients that can be identified with a ROC-analysis.
Moreover the correlation between capnovolumetry and the parameters of the bodyplethysmography will be investigated in an exploratory manner in order to determine a possible additional benefit in the detection of emphysema and increased dead space volume.

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

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/02/12
  •   1280
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Adult patients
- who confirm their participation in the study in written form and
- who will obtain a routine lung function testing

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

Exclusion Criteria

- missing informed consent form
- age under 18 years
- deficient knowledge of the German language inhibiting the understanding of the sense of the study

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum rechts der Isar, Institut für Allgemeinmedizin
    • Mr.  Prof. Dr. med.  Antonius  Schneider 
    • Orleansstr. 47
    • 81667  München
    • 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
    • Zentrum für Pneumologie, Onkologie und Schlafmedizin am DiakonissenkrankenhausAugsburg, Dres. Hellmann, Wehgartner-Winkler, Faderl, Dankelmann, Vitiello, Prof.Schlimok
    • Mr.  Dr. med.  Andreas  Hellmann 
    • Frölichstraße 17
    • 86150  Augsburg
    • 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
    • Klinikum rechts der Isar der TU MünchenInstitut für Allgemeinmedizin
    • Mr.  Prof. Dr. med.  Antonius  Schneider 
    • Ismaninger Str. 22
    • 81675  München
    • 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
    • Klinikum rechts der Isar der TU MünchenInstitut für Allgemeinmedizin
    • Mr.  Prof. Dr. med.  Antonius  Schneider 
    • Ismaninger Str. 22
    • 81675  München
    • 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
    • Ganshorn Medizin Electronic GmbH
    • Mr.  Jürgen  Behringer 
    • Industriestr. 6-8
    • 97618  Niederlauer
    • 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 ongoing
  •   [---]*
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.