Ultrasound vs. Auscultation and Fiberoptic Bronchoscopy for Double-Lumen Tube Placement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIzmir City Hospital
About this trial
One-lung ventilation is frequently required in thoracic surgery and is most commonly achieved using double-lumen endobronchial tubes (DLTs). Correct positioning of the DLT is crucial for effective lung isolation and patient safety. Fiberoptic bronchoscopy (FOB) is considered the gold standard for confirming DLT placement; however, it may not always be immediately available and requires specific expertise.
Lung ultrasonography is a rapid, noninvasive, and bedside imaging method increasingly used in anesthesiology and critical care. This prospective observational study aims to evaluate the diagnostic performance of lung ultrasound in confirming the correct position of double-lumen endobronchial tubes in patients undergoing thoracic surgery.
The results obtained from lung ultrasound will be compared with auscultation findings and fiberoptic bronchoscopy results. Fiberoptic bronchoscopy will be considered the reference standard. The sensitivity, specificity, positive predictive value, and negative predictive value of lung ultrasound and auscultation will be calculated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 65 years
Scheduled for elective thoracic surgery
Planned one-lung ventilation
Use of double-lumen endobronchial tube
Disqualifiers
Known airway anomalies
Previous lung resection surgery
Tracheostomy
Coagulopathy
Trial population
Adult patients aged 18-65 years undergoing elective thoracic surgery requiring one-lung ventilation with a double-lumen endobronchial tube at Izmir City Hospital will be included in this study. Patients will be recruited consecutively after providing written informed consent. The position of the double-lumen tube will be evaluated using auscultation and lung ultrasonography and confirmed by fiberoptic bronchoscopy as part of routine clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Thoracic surgery patients undergoing one-lung ventilation with double-lumen tube
Trial outcomes
Primary outcomes
1
Diagnostic accuracy of lung ultrasound for confirmation of double-lumen tube placement
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of lung ultrasound in confirming correct double-lumen endobronchial tube placement compared with fiberoptic bronchoscopy as the reference standard.
Time frame
Intraoperative (immediately after DLT placement)Secondary outcomes
1
Agreement between methods
Agreement between lung ultrasound, auscultation, and fiberoptic bronchoscopy in confirming DLT position will be evaluated using Cohen's kappa coefficient.
Time frame
Intraoperative2
Diagnostic accuracy of auscultation for confirmation of double-lumen tube placement
Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of auscultation for confirming correct double-lumen tube placement compared with fiberoptic bronchoscopy.
Time frame
Intraoperative3
Time required to confirm correct double-lumen tube placement
Time required to confirm correct double-lumen endobronchial tube position using lung ultrasound, auscultation and fiberoptic bronchoskopy.
Time frame
Immediately after tube placement4
Effect of right- versus left-sided double-lumen endobronchial tubes on diagnostic performance
Comparison of the diagnostic performance of lung ultrasound and auscultation for confirming correct double-lumen endobronchial tube position in right-sided versus left-sided double-lumen tubes, using fiberoptic bronchoscopy as the reference standard. Measures will include sensitivity, specificity, PPV, NPV, and overall accuracy within each DLT type.
Time frame
ıntraoperative (immediately after DLT placement)Sponsors and contacts
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Source ClinicalTrials.gov