This double-blind study was conducted on 116 consecutive patients. Based on previous studies and considering a sensitivity of 96%, specificity of 93%, a likelihood ratio of 13, and an α value of 5%, with a confidence interval of 95% using the LR formula, we calculated that the study should include at least 76 patients. The patients were referred to Nemazee hospital, affiliated with Shiraz University of Medical Sciences, from August 2013 to January 2014, with indications for elective cardiac surgery and CVC placement.
The exclusion criteria were age under 18 years, recent abdominal and/or chest surgery, and CVC placement in an emergency situation. Written informed consent was obtained from all patients. The study was approved by the ethics committee of Shiraz University of Medical Sciences.
Under general anesthesia, a triple-lumen 7F, 15- or 20-cm CVC (Arrow International, Inc.) was placed using anatomical landmarks with the Seldinger technique. No sonographic guidance was used during the catheter placement. The insertion approach was chosen based on the anesthesiologist’s preference.
After catheter insertion by an anesthesiology resident, CEUS was performed by another anesthesiology resident who had undergone two days of theory-based teaching sessions on cardiac-focused ultrasonography with an expert cardiologist, with an emphasis on the subxyphoid view. The resident was also trained by an expert radiologist to perform Doppler ultrasonography of the carotid and axilla to detect extrathoracic catheter misplacement. Finally, the resident performed 150 CEUS procedures before the start of the study.
Ultrasound examination was performed through epigastric and subcostal acoustic windows along the short heart axis using a 3S-RS, 1.5 - 3.6 MHZ probe (GE vivid S5 cardiovascular ultrasound machine, USA), which made possible the simultaneous visualization of the superior vena cava (SVC), inferior vena cava (IVC), and right atrium (RA) (
Figure 1). To detect catheter position by CEUS, we used the standard technique applied by cardiologists for the diagnosis of a patent foramen ovale (
12).
Image is taken from a video clip recorded with the handycam. AO, aorta; IVC, inferior vena cava; RA, right atrium; SVC, superior vena cava.
Two 10-mL syringes, one containing 9 mL of saline and the other containing 1 mL of air, were connected to a 3-way stopcock. The saline and air were mixed through the stopcock until a homogenous mixture of air and saline was achieved. The stopcock was attached to the lumen of the catheter, ending at its tip. Next, 5 mL of the solution was injected rapidly through the catheter. Interpretation of the microbubble test was performed using the criteria described by Vezzani and colleagues (
Table 1) (
12). A stream of microbubbles with laminar jet flow from the SVC within 1 - 2 seconds after the injection indicated correct catheter location (
Figure 2). Incorrect placement was defined as turbulent flow coming from the RA or the IVC. The second injection was done only if the catheter location was not confirmed with certainty. If no bubbles were seen, Doppler sonography of the axillary and jugular veins was performed to assess misplacements in these locations, and if the catheter was not seen in these locations, evaluation of the catheter site with fluoroscopic guidance before the start of surgery was planned.
| Characteristic | Interpretation |
|---|
| No bubbles | Negative test: an aberrant or too-distal tip position must be considered. |
| Few bubbles or appearance time > 2 sec | Test to be repeated: if confirmed, possible misplacement (probably in SV or IJV). |
| Numerous bubbles indistinguishable separately; turbulent flow coming from the atrium within 2 sec | Negative test: intra-atrial positioning. |
| Numerous bubbles indistinguishable separately; linear flow coming from SVC | Positive test: CVC tip correctly placed in the SVC. |
Abbreviations: CVC, central venous catheter; IJV, internal jugular vein; SVC, superior vena cava; subclavian vein.
All of the ultrasonography video clips were recorded, but only the clips from suspicious cases were reviewed and evaluated for a microbubble flow pattern. After the operation was completed and the patient was transferred to the ICU, portable anteroposterior chest radiography was performed. The results were reported by an expert radiologist who was blinded to the ultrasonography results. Identification of the catheter in the SVC or SVC–RA junction was considered correct placement. Visualization of the catheter tip in any other position was defined as CVC misplacement.
3.1. Statistical Analysis
Analysis was performed using SPSS 19.00 for Windows (SPSS Inc. IBM Corp., Chicago, IL, USA) and continuous variables were presented as the mean (±SD). Sensitivity, specificity, and predictive values were determined by comparing ultrasonography results with radiographic findings as the reference standard. For calculating concordance between CEUS and CXR, the қ statistic was used. P values of < 0.05 were considered statistically significant.