Trial document




drksid header

  DRKS00009447

Trial Description

start of 1:1-Block title

Title

Hemodynamic implications of laparoscopic surgery in Neonates and Infants compared to the open approach

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

Trial Acronym

LiDCOlapScop

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

URL of the Trial

http://Keine

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

Brief Summary in Lay Language

The purpose of this clinical study is to investigate whether changes in cardiac circulatory system (cardiac output, blood pressure behavior) take place in children that undergo an abdominal operation, either as part of a laparoscopic procedure without any major incision in the abdominal wall (= so-called keyhole surgery) or by opening the abdominal wall (= so-called open surgery). After induction of general anesthesia (= anesthetic) and the routine insert an arterial cannula the LIDCO device is pluged into the surveillance monitor, not connected to their child. To calibrate this system a transthoracic cardiac ultrasound (= external) is conducted before the operation starts. The only, just because of the study performed actions are the heart ultrasound examination and the attachment of the
LIDCO device to the patient monitor, all so-called non-invasive measures, not the body penetrating or hurtful measures.

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

Brief Summary in Scientific Language

The application of pulse contour analysis technique, which provides changes in stroke volume for each heart beat by calculating the nominal stroke volume from a print volume transform the radial artery pressure waveform, is safe and is approved for use in patients since 2003 as a minimally invasive hemodynamic monitoring of cardiac output approved. The LiDCO device is particularly suitable for patients who have only one arterial and venous access (peripheral or central). The present study may provide information whether the application of this minimally invasive hemodynamic monitoring system, the evaluation and treatment of the volume status of the patient intraoperatively is improved in neonates and infants undergoing laparoscopic or open abdominal surgery.
Since the pulse contour analysis via LiDCO hemodynamic monitoring, by measuring the "beat-to-beat" cardiac output and oxygen delivery (without the need of advanced invasive measures), improving the global supply of oxygen can be maximized without the risk of fluid overload. This research provides a hemodynamic foundation, which enable new diagnostic possibilities and can have a significant impact on laparoscopic surgery, so this particular group of patients of very sick newborns and infants, these invasive procedures can be performed safely.

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

Organizational Data

  •   DRKS00009447
  •   2015/10/27
  •   [---]*
  •   yes
  •   Approved
  •   1519/2015, Ethikkommission der Medizinischen Universität Wien
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

  •   Hemodynamic implications of laparoscopic surgery
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Hemodynamic parameters during open abdominal surgery.
  •   Hemodynamic parameters during laparoscopic surgery.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

To describe the hemodynamic changes (via LIDCO) in Neonates and infants compared in laparoscopic versus open approach

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

Secondary Outcome

There are respiratory changes while mechanical ventilation (VT;PIP) in patients with laparoscopic surgery

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

Countries of Recruitment

  •   Austria
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
  •   2016/01/01
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   0   Months
  •   12   Months
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Major abdominal surgery, laparoscopic or open approach, in Neonates and infants (aged ≤ 1 year)

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

Exclusion Criteria

Parent's refusal of participation of their child in the study

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Universität Wien
    • Mr.  Prof. Dr  Klaus  Markstaller 
    • Spitalgasse 23
    • 1090  Wien
    • Austria
    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
    • Medizinische Universität Wien
    • Mr.  Dr  Triffterer  Lydia 
    • Spitalgasse 23
    • 1090  Wien
    • Austria
    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
    • Medizinische Universität Wien
    • Dr  Werner  Schmid 
    • Währinger-Gürtel 18-20
    • 1090  Wien
    • Austria
    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
    • Anästhesie, Allgemiene Intensivmedizin und Schmerztherapie
    • Mr.  Univ.- Prof. Dr.  Klaus  Markstaller 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
    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.