Trial document




drksid header

  DRKS00020216

Trial Description

start of 1:1-Block title

Title

Sonography versus roentgenogram after thoracic surgery

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

Trial Acronym

SONOR2

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

After chest surgery, radiographs are taken regularly to determine whether the lungs are fully extended, whether there is fluid retention in the chest, and whether there is inflammation or bleeding. Of particular interest is whether there is a pneumothorax, i.e. whether air has escaped from the lungs. There are indications that a simple ultrasound examination could be as helpful as X-rays. The advantage of ultrasound is that it does not require radiation. In patients with lung surgery, we want to perform ultrasound in addition to X-rays and compare the accuracy of the two examination methods.

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

Brief Summary in Scientific Language

Transthoracic lung sonography has developed into a simple, fast, radiation-free and versatile alternative to X-rays in many areas. It is, for example, suitable for the emergency examination of critically ill patients, for the detection of spontaneous, traumatic or interventional pneumothorax, for therapy monitoring of pulmonary edema or pneumonia. In these applications it is superior to X-rays in diagnostic (sensitivity, negative predictive value) and practical terms (examination of lying patients, independence from radiological personnel, ubiquitous and immediately available). However, as the list suggests, most of the examinations come from internal intensive care medicine and traumatology. There is very little data from thoracic surgery that would benefit from a radiation-free alternative, especially through routine postoperative X-ray thoracic controls. The previous studies including our own SONOR study are very heterogeneous with sensitivities between 18% and 100%. Possible causes are unsuitable technology (modern ultrasound equipment filters the decisive artifacts and reduces the significance of pleuropulmonary ultrasound), inadequate methodology, ambiguity about the optimal examination position and sometimes very restrictive "academic" selection criteria that cannot be transferred to daily routine.
A major interest after thoracic surgery is the residual pneumothorax, which determines the duration of the drainage treatment. SONOR had shown a sensitivity of 32% for all pneumothoraces, including the smallest, increasing to 100% for ≥3cm large pneumothorax. In fact, these are the relevant Pneumothoraces, which usually require re-drainage. However, the prevalence of Pneumothorax naturally decreases with its size, so that the data from SONOR for Pneumothoraces ≥1cm show insufficient statistical power. In addition, we have learned methodological subtleties with which we expect a higher sensitivity per se in the future. The present SONOR-2 study is therefore intended to evaluate the test parameters with improved methodology and an increased number of cases.

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?

No

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

  •   DRKS00020216
  •   2019/12/03
  •   [---]*
  •   yes
  •   Approved
  •   140/2019, Ethik-Kommission der Universität Witten/Herdecke
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1244-8088 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J93.8 -  Other pneumothorax
  •   J90 -  Pleural effusion, not elsewhere classified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with an indication for lung or chest wall resection surgery except for pneumonectomy receive a systematic ultrasound examination of the thorax on the first postoperative day and after removal of the chest tube in addition to the standard X-ray image. The results of both types of examination 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 lung ultrasound compared with chest X-ray for a residual pneumothorax of at least 1.5cm size (apex-to-cupola in upright chest roentgenogram) after removing the chest tube

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

Secondary Outcome

Specificity, predictive values, likelihood ratios, diagnostic odd's ratio, test parameters for other pneumothorax cut-off values, test parameters for other pleural or pulmonary pathologies, all compared with chest roentgenogram

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

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/12/08
  •   200
  •   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 or chest wall resection including visceral decortication, pulmotomy and bronchotomy, except pneumonectomy

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

Exclusion Criteria

pregnancy

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Lungenklinik 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
    • Lungenklinik Kliniken der Stadt Köln gGmbH, Standort Merheim
    • Mr.  Dr.  Thomas  Galetin 
    • Ostmerheimerstraße 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
    • Lungenklinik Kliniken der Stadt Köln gGmbH, Standort Merheim
    • Mr.  Dr.  Thomas  Galetin 
    • Ostmerheimerstraße 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
    • Lungenklinik Kliniken der Stadt Köln gGmbH, Standort Merheim
    • Ostmerheimerstraße 200
    • 51109  Köln
    • 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.