Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003338

Trial Description

start of 1:1-Block title

Title

Incidence of aspiration and effect on the morbidity in just before intubated patients in case of emergency. Value of biomarkers relating to ALI/ARDS.

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 study analyses the frequency of an aspiration in patients who were just before intubated. Patients receiving at the ICU will be included. After the intubation the secret is taken. The tracheal secret will be analysed for markers of an aspiration.
The clinical outcome of the patients will be taken into consideration. The study tests the hypothesis that an aspiration is more often than assumed based on the anamnesis and has an influence on the outcome of the patients.

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

Brief Summary in Scientific Language

Incidence of aspiration and effect on the morbidity in just before intubated patients in case of emergency. Value of biomarkers relating to ALI/ARDS.

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

  •   DRKS00003338
  •   2012/01/18
  •   [---]*
  •   yes
  •   Approved
  •   236/11, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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

  •   J69 -  Pneumonitis due to solids and liquids
  •   J80 -  Adult respiratory distress syndrome
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   ICU-Group: The study analyses the frequency of an aspiration in patients who were just before intubated. Patients receiving at the ICU will be included. After the intubation the secret is taken. The tracheal secret will be analysed for markers of an aspiration.
    The clinical outcome of the patients will be taken into consideration. The study tests the hypothesis that an aspiration is more often than assumed based on the anamnesis and has an influence on the outcome of the patients.

  •   control group: in patients who underwent an elective bronchoscopy tracheal secret will analyzed for markers of an aspiration.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Incidence of aspiration after intubation (emergency)

- Incidence of Pneumonitis/Pneumonia/ventilator associated pneumonia in case of aspiration

- predictive value of detection of pepsin and bile acids in the tracheal secretion (diretly after intubation) vs. standard (suspicion of aspiration, noticed aspiration).

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

Secondary Outcome

- distribution of the pH in the oncdensate of breathing gas

- distribution of the pH in tracheal liquid/tracheal secret of intubated patients
(emergency)

- distribution of uric acid
in tracheal liquid/tracheal secret of intubated patients (emergency)

- distribution of glucose in tracheal liquid/tracheal secret of intubated patients (emergency)

- distribution of IL-6 in tracheal liquid/tracheal secret of intubated patients (emergency)

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

  •   Actual
  •   2011/12/12
  •   70
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

1) intubation jsut before
2) medical diagnosis
3) taking of tracheal secret possible within 6 hours after intubation

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

Exclusion Criteria

1) circulatory insufficiency
2) fiO2> 80%
3) PEEP > 15 mmHg
4) severe lung disease
5) intubation caused by pneumonia
6) stroke in medical history
7) neuromuscular disease
8) pretreatment with antibiotics
9) non invasive ventilation
10) LTX in medical history
11.) gastrectomy in medical history

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Gießen und Marburg Medizinische Klinik II
    • Mr.  Prof. Dr.   Dieter  Walmrath 
    • Klinikstr. 33
    • 35392  Gießen
    • 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
    • Universitätsklinikum Gießen und Marburg Medizinische Klinik II
    • Mr.  Prof. Dr.   Dieter  Walmrath 
    • Klinikstr. 33
    • 35392  Gießen
    • 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 Gießen und Marburg Medizinische Klinik II
    • Mr.  Prof. Dr.   Dieter  Walmrath 
    • Klinikstr. 33
    • 35392  Gießen
    • 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
    • Justus Liebig Universität Gießen
    • Mr.  Prof. Dr.  Dieter  Walmrath 
    • Klinikstr. 33
    • 35392  Gießen
    • 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.