This diagnostic accuracy study, conducted according to STARD guidelines, enrolled 120 cancer cases aged ≥ 18 years undergoing thoracic surgery and requiring DLT intubation at the National Cancer Institute (NCI) after obtaining written informed consent and after approval of the Institutional Review Board (IRB: 202101-2P-02002) and registration at clinical trials.gov (ID: NCT04740385) from February 2021 to June 2022.
Cases with expected airway difficulty or an in-situ tracheostomy tube, previous lung surgery, pleural effusion, pneumothorax, pleurodesis, or absent lung sliding sign were excluded. We performed a complete history taking, clinical examination, specifically of the airway, routine laboratory tests, and additional tests based on the patient's medical history.
In the waiting area, all patients were clinically examined using a stethoscope, auscultation, and LUS to confirm the presence of lung sliding signs. Patients with absent lung sliding signs were excluded.
Induction of general anesthesia (GA) was performed by propofol 2 mg/kg and fentanyl 2 µ/kg IV. Laryngoscopy was facilitated by rocuronium 0.6 mg/kg followed by intubation by DLT (COVIDIEN, Shiley) sized (35, 37, or 39 F) according to sex and height. GA was maintained using isoflurane 1 - 1.5% through positive pressure mechanical ventilation and rocuronium top-up doses. All the DLT inserted were left-sided, as, in our institute, we routinely use left DLT except in rare cases where right DLT insertion is mandatory.
After confirmation of intubation by capnography and confirming normal airway pressure, confirmation of DLT placement was done through auscultation in the supine position, then by LUS, and finally by FOB.
All procedures were conducted by two professional anesthesiologists with a complete agreement between them (κ = 0.99).
3.1. Auscultation
After insertion of the DLT, the tracheal cuff was initially inflated, then auscultation of the upper and lower chest zones on both sides were done. This was followed by inflation of the bronchial cuff and repeated auscultation of the same regions, first with the tracheal lumen clamped and finally with the bronchial lumen clamped. Correct intubation of the DLT was confirmed by the existence of symmetrical bilateral lung sounds prior to clamping of the tracheal lumen, then by a reduction in the whole sound of the right lung and the appearance of symmetrical upper and lower lung sounds in the left lung following tracheal lumen clamping. This was followed by a reduction in the whole sound of the left lung and the appearance of symmetrical upper and lower lung sounds in the right lung following bronchial lumen clamping.
Time to confirm tube position was calculated starting from auscultation to the end of DLT position confirmation.
3.2. Lung Ultrasound
After auscultation, an LUS examination was performed on both sides of the anterior and lateral chest wall by low frequency (5 - 10 MHz) curved probe of Sonosite M-Turbo ultrasound machine (FUGIFILM Sonosite, Inc., Bothel, WA 98021, USA). LUS was done on four quadrants bilaterally in the supine position.
LUS scanning was done in eight areas. The chest areas were divided on each side into two anterior and two lateral areas. Anterior areas were outlined from the sternum to the anterior axillary line, while the lateral areas were from the anterior to the posterior axillary line. Each anterior and lateral area was further divided into upper and lower areas from the clavicle to the second-third intercostal spaces and from the third space to the diaphragm. The correct position of the DLT was confirmed with a loss of lung sliding sign on the same clamped lumen side.
Time was calculated from the probe to the chest position until confirmation by the absence of lung pleura sliding.
3.3. Fiberoptic Bronchoscopy
Tube position was initially checked using FOB (Karl Storz, Germany, Tuttlingen, Germany) as a reference standard through the tracheal lumen and then through the bronchial lumen.
The correct DLT placement criteria were: (1) the tracheal rings are seen anteriorly and the muscular stria posteriorly, (2) the bronchial cuff is seen below the carina and just above the left bronchus, (3) the tip of the tube is positioned just above the secondary carina through the bronchial lumen.
The incorrect DLT placement criteria were: (1) absence of the tracheal rings (esophageal or bronchial intubation), (2) too shallow, defined as more than 50% of the right bronchus opening is obscured by the bronchial cuff, (3) too deep, defined as either the bronchial cuff after inflation was totally unseen or when the tip of the bronchial tube is seen under the secondary carina.
To calculate the accuracy of auscultation and LUS compared to FOB:
• True positive (TP) result was described as a situation wherein auscultation, or LUS indicated the correct DLT placement, which was verified by FOB.
• True negative (TN) result was described as a situation in which auscultation or LUS revealed incorrect DLT placement that was verified by FOB.
• False positive (FP) results were described as a situation wherein auscultation, or LUS, revealed a correct DLT placement, but FOB revealed the incorrect placement.
• False negative (FN) results were characterized as a situation wherein auscultation or LUS revealed incorrect DLT placement, which was verified to be accurate following FOB.
The primary outcome was the accuracy of LUS. Secondary outcomes included procedural time and agreement between LUS and FOB findings.
3.4. Sample Size Calculation
Based on the previous paper by Parab et al., 2015 (
12), the expected sensitivity of the traditional auscultation method is 75% with 18% specificity. Using 90% power, 5% significance level, and 95% confidence interval, at least 114 patients are required. We added six cases to overcome dropout. Therefore, 120 cases were recruited. The sample size calculation was done based on the Arifin sample size calculator 2017.
3.5. Statistical Analysis
Statistical analysis was done by SPSS v26 (IBM Inc., Chicago, IL, USA). Quantitative variables were expressed as average and standard deviation (SD). Qualitative variables were expressed as frequency and percentage. Times were compared by repeated measure ANOVA. Sensitivity, specificity, and accuracy were measured to validate the DLT placement compared to the FOB findings. Kappa test indicated agreement with FOB results. A two-tailed P value was considered significant.