Trial document




drksid header

  DRKS00013670

Trial Description

start of 1:1-Block title

Title

Influence of rigid cervical collar on ICP and intracerebral Oxygen pressure

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

As ICP might rise while carrying a rigid cervical collar due to venous occlusion, we conducted this study to show the influence of a rigid cervical collar on ICP. Therefor 50 patients should be included, who got an ICP-Monitoring because of a brain injury. Only patients with normal ICP should be included and treatment will be stopped when ICP is rising above 20 mmHg.

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

Brief Summary in Scientific Language

As ICP might rise while carrying a rigid cervical collar due to venous occlusion, we conducted this study to show the influence of a rigid cervical collar on ICP. Therefor 50 patients should be included, who got an ICP-Monitoring because of a brain injury. Only patients with normal ICP should be included and treatment will be stopped when ICP is rising above 20 mmHg.

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

Organizational Data

  •   DRKS00013670
  •   2018/01/17
  •   [---]*
  •   yes
  •   Approved
  •   D456/17, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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

  •   S06.3 -  Focal brain injury
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   50 patients are treated with a rigid cervical collar.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

In this study the influence of a rigid cervical collar on ICP and intracerebral Oxygen pressure should be investigated. Therefor patients, who have already received monitoring of ICP and Oxygen pressure get a rigid cervical collar for 30 minutes. ICP and Oxygen pressure are monitored during the Intervention.

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

Secondary Outcome

[---]*

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
  •   2018/01/17
  •   50
  •   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

For this study patients, who had a brain injury and got an ICP-Monitoring, should carry a rigid cervical collar.

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

Exclusion Criteria

ICP-fluctuations above 5 mmHg
Hemicraniectomy
vasospasm

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Neurochirurgie, UKSH Kiel
    • Mr.  Prof.Dr.  Michael  Synowitz 
    • Arnold-Heller-Str.3
    • 24105  Kiel
    • 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
    • UKSH Kiel
    • Ms.  Dr.  Ann-Kristin  Helmers 
    • Arnold-Heller-Straße 3
    • 24150  Kiel
    • 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
    • UKSH Kiel
    • Ms.  Dr.  Ann-Kristin  Helmers 
    • Arnold-Heller-Straße 3
    • 24150  Kiel
    • 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
    • UKSH Kiel Klinik für Neurochirurgie
    • Arnold-Heller-Str.3
    • 24105  Kiel
    • 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.