Trial document




drksid header

  DRKS00014557

Trial Description

start of 1:1-Block title

Title

Point-of-Care Ultrasound Diagnostics of the Lung - New Areas of Application in Anaesthesiology and Thoracic Surgery

Study 2: Use of ultrasound for postoperative controls after lung resection surgery

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

Trial Acronym

SONOR

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

Patients undergoing thoracic surgery receive thoracic drainage during the operation, a tube that transports air and secretions from the chest immediately after the operation and during the healing phase. By means of the chest tube it is possible to determine whether there is still a small air leakage in the lungs. On the first postoperative day and after removal of the chest tube, an x-ray is taken as standard to check whether the lung has fully expanded. There are hints that the ultrasound examination of the chest could be at least as accurate as the standard method. In contrast to x-rays, however, ultrasound is less harmful to the body because no ionising radiation is used.
In patients undergoing thoracic surgery, we would like to use ultrasound in addition to monitoring the lungs in the post-anaesthesia care unit and x-ray and compare whether the ultrasound is equivalent. The ultrasound examination has no known side effects.

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

Brief Summary in Scientific Language

A reliable sonographic evaluation of pulmonary structures was considered impossible for a long time, since the sound waves in air-filled rooms and tissues are not transmitted and thus deeper structures are not included in the image. However, it has been shown that the representation of pleural interfaces, parenchymatous structures and the resulting sonographic artefacts and phenomena allow a reliable diagnosis. The first ultrasound diagnosis of a pneumothorax was described in 1986 in veterinary medicine. Subsequently, pulmonary ultrasound was also introduced in human medicine and has become increasingly important. However, the establishment as bed-side routine diagnostics was only made possible by the development of smaller portable ultrasound devices. At present, ultrasound in the intensive care unit is already replacing the classical radiographs of the thorax for numerous problems (e.g. pneumothorax, pleural effusion, infiltrations). These developments are based on the high sensitivity and specificity of sonography for the detection of pleural and pulmonary pathologies, the comparatively steep learning curve, the ubiquitous availability and the avoidance of ionizing radiation and intra-hospital transports.
Essential pathologies such as pulmonary oedema, pleural effusion and pneumothorax can be detected by the lung gliding (breath-shifting gliding of the visceral at the parietal pleura), the A-lines (an artefact parallel to the pleural line) and the B-lines (artefacts parallel to the sound direction) in the B- and M-mode of the ultrasound device. The determination of the so-called "lung point" (point of sonographic reunification of the visceral and parietal pleura after air-induced separation by a pneumothorax) allows the semiquantification of a pneumothorax.
In contrast to intensive care and emergency medicine, pulmonary ultrasound is currently rarely used in anaesthesia and in the normal surgical ward, although thoracic surgery in particular offers a wide range of possible applications. The interdisciplinary evaluation of pulmonary ultrasound in various areas of thoracic anaesthesia and thoracic surgery to reduce the resource-intensive and potentially harmful equipment routine diagnostics is the subject of this research project. The benefit of lung sonography is to be examined for monitoring the course of postoperative pathologies.

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

  •   DRKS00014557
  •   2018/09/06
  •   [---]*
  •   yes
  •   Approved
  •   38/2018, Ethik-Kommission der Universität Witten/Herdecke
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1219-6898 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J95.80 -  [generalization J95.8: Other postprocedural respiratory disorders]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with lung resection thoracic surgery receive a standard x-ray on the first postoperative day and after removal of the chest tube. During the study, patients will also receive an additional thoracic ultrasound at three times (in the recovery room, on the first postoperative day and after removal of the chest tube). Sonography and X-rays are compared.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   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

Sensitivity of thoracic ultrasound for postoperative pneumothorax after removal of the chest tube, controlled by X-ray.

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

Secondary Outcome

Specificity of pulmonary sonography for a pneumothorax after removal of chest tube after lung resection thoracic surgery compared to conventional chest x-ray.
Sensitivity and specificity of lung sonography for a pneumothorax 2 hours after lung resection thoracic surgery in the recovery room, measured at the reference of the chest tube (air leakage).
Sensitivity and specificity of pulmonary sonography for a pneumothorax on the first day after lung resecting surgery
Detection of pleural effusions
Detection of parenchymal changes
examination duration
Real or potential damages of the diagnostics are quantified (radiation dose)
Differences in the assessment of the relevance of a detected pneumothorax
Comparison of resources used

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
  •   2018/08/31
  •   121
  •   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

lung resecting thoracic surgery
capable patient
consent

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

Exclusion Criteria

- Persons who are dependent on or employed by the sponsor or investigator
- Accommodation in an institution due to a court or official order
- Disable patient who is unable to understand the nature, meaning and scope of the study
- Pregnancy and lactation

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Kliniken der Stadt Köln gGmbH, Standort Merheim
    • Ostmerheimerstraße 200
    • 51109  Köln
    • 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
    • Klinikum der Universität Witten/Herdecke - KölnKlinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Dr.  Jérôme  Défosse 
    • Ostmerheimer Straße 200
    • 51109  Köln
    • 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 der Universität Witten/Herdecke - KölnKlinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Dr.  Jérôme  Défosse 
    • Ostmerheimer Straße 200
    • 51109  Köln
    • 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
    • Private Universität Witten/Herdecke Interne Forschungsförderung
    • Alfred-Herrhausen-Straße 50
    • 58448  Witten
    • 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 complete, follow-up complete
  •   2019/04/30
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.