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Clinical Trials/DRKS00014557
DRKS00014557
Completed
Not Applicable

Point-of-Care Ultrasound Diagnostics of the Lung - New Areas of Application in Anaesthesiology and Thoracic SurgeryStudy 2: Use of ultrasound for postoperative controls after lung resection surgery - SONOR

Kliniken der Stadt Köln gGmbH, Standort Merheim0 sites136 target enrollmentSeptember 6, 2018
ConditionsJ95.80

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
J95.80
Sponsor
Kliniken der Stadt Köln gGmbH, Standort Merheim
Enrollment
136
Status
Completed
Last Updated
last year

Overview

Brief Summary

Abstract Objectives: Thoracic ultrasound is superior to chest X-ray for the detection of a pneumothorax in trauma and intensive care medicine. Data regarding its use in non-cardiac thoracic surgery are scarce and contradictory. Previous studies are heterogeneous regarding sonographic methodology and patient selection. This study aimed to evaluate the accuracy of thoracic ultrasound for pneumothorax assessment after lung resecting surgery in unselected patients. Methods: SONOR (SONOgraphy vs x-Ray) is a prospective observational trial (registry-ID DRKS00014557). A total of 123 consecutive patients with lung resecting surgery received a standardized thoracic ultrasound the same day and in addition to routine chest X-rays in erect position after removal of the chest tube. The sonographer was blinded to radiological findings and vice versa. Results: Sensitivity, specificity, positive and negative predictive values of ultrasound after removing the chest tube were 0.32, 0.85, 0.54, 0.69 for any pneumothorax and 1.0, 0.82, 0.19, 1.0 for pneumothorax =3 cm. No clinically relevant pneumothorax was missed. The agreement between sonography- and routine-based therapeutic decisions was 97%. Lung pulse was the most frequently detected sign to sonographically rule out a pneumothorax. Conclusions: Postoperative thoracic ultrasound in unselected patients has a low overall sensitivity to detect a residual pneumothorax; however, its sensitivity and negative predictive values regarding clinically relevant pneumothorax are high. Test quality depends on the distinct sonographic methodology and patient selection. Anatomic differences in postsurgical and medical patients may be responsible for the contradictory results of previous trials. Studies with a larger population size are required to validate the accuracy of relevant pneumothoraces and identify appropriate selection criteria.

Registry
who.int
Start Date
September 6, 2018
End Date
April 30, 2019
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Kliniken der Stadt Köln gGmbH, Standort Merheim

Eligibility Criteria

Inclusion Criteria

  • lung resecting thoracic surgery
  • capable patient

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

Outcomes

Primary Outcomes

Not specified

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