Spectral tissue sensing to identify intra- and extravascular needle placement - A randomized single-blind controlled trial.

Safe vascular access is a prerequisite for intravenous drug admission. Discrimination between intra- and extravascular needle position is essential for procedure safety. Spectral tissue sensing (STS), based on optical spectroscopy, can provide tissue information directly from the needle tip. The primary objective of the trial was to investigate if STS can reliably discriminate intra-vascular (venous) from non-vascular punctures. In 20 healthy volunteers, a needle with an STS stylet was inserted, and measurements were performed for two intended locations: the first was subcutaneous, while the second location was randomly selected as either subcutaneous or intravenous. The needle position was assessed using ultrasound (US) and aspiration. The operators who collected the data from the spectral device were blinded to the insertion and ultrasonographic visualization procedure and the physician was blinded to the spectral data. Following offline spectral analysis, a prediction of intravascular or subcutaneous needle placement was made and compared with the "true" needle tip position as indicated by US and aspiration. Data for 19 volunteers were included in the analysis. Six out of 8 intended vascular needle placements were defined as intravascular according to US and aspiration. The remaining two intended vascular needle placements were negative for aspiration. For the other 11 final needle locations, the needle was clearly subcutaneous according to US examination and no blood was aspirated. The Mann-Whitney U test yielded a p-value of 0.012 for the between-group comparison. The differences between extra- and intravascular were in the within-group comparison computed with the Wilcoxon signed-rank test was a p-value of 0.022. In conclusion, STS is a promising method for discriminating between intravascular and extravascular needle placement. The information provided by this method may complement current methods for detecting an intravascular needle position.

The Role of Spectral Tissue Sensing During Lumbar Transforaminal Epidural Injection.

Spectral tissue sensing (STS) exploits the scattering and absorption of light by tissue. The main objective of the present study was to determine whether STS can discriminate between correct and incorrect placement of the needle tip during lumbar transforaminal epidural injection. This was a single-blind prospective observational study in 30 patients with lumbar radicular pain scheduled for lumbar transforaminal epidural injection. Spectral tissue sensing data from the needle tip were acquired along the needle trajectory at 4 predefined measurement points and compared with ultrasound, fluoroscopy, and digital subtraction angiography images. Spectral tissue sensing data contained the full spectra. The lipid and hemoglobin content at the different measurement points was also calculated, and partial least-squares discriminant analysis was used to estimate the sensitivity and specificity of STS. Spectral tissue sensing identified correct needle placement with a sensitivity of 57% and a specificity of 82%, and intraforaminal versus extraforaminal locations were identified with a sensitivity of 80% and a specificity of 71%.

Optical detection of peripheral nerves: an in vivo human study.

BACKGROUND AND OBJECTIVES: A critical challenge encountered in interventional pain medicine procedures is to accurately and efficiently identify transitions to peripheral nerve targets. Current methods, which include ultrasound guidance and nerve stimulation, are not perfect. In this pilot study, we investigated the feasibility of identifying tissue transitions encountered during insertions toward peripheral nerve targets using optical spectroscopy. METHODS: Using a custom needle stylet with integrated optical fibers, ultrasound-guided insertions toward peripheral nerves were performed in 20 patients, with the stylet positioned in the cannula of a 20-gauge stimulation needle. Six different peripheral nerves were represented in the study, with 1 insertion per patient. During each insertion, optical reflectance spectra were acquired with the needle tip in subcutaneous fat, skeletal muscle, and at the nerve target region. Differences in the spectra were quantified with 2 parameters that provide contrast for lipid and hemoglobin, respectively. RESULTS: The transition of the needle tip from subcutaneous fat to muscle was associated with lower lipid parameter values (P = 0.003) and higher hemoglobin parameter values (P = 0.023). The transition of the needle tip from the muscle to the nerve target region was associated with higher lipid parameter values (P = 0.008). CONCLUSIONS: The results indicate that the spectroscopic information provided by the needle stylet could potentially allow for reliable identification of transitions from subcutaneous fat to skeletal muscle and from the muscle to the nerve target region during peripheral nerve blocks.

Optical detection of vascular penetration during nerve blocks: an in vivo human study.

BACKGROUND AND OBJECTIVES: Complications resulting from vascular penetration during nerve blocks are rare but potentially devastating events that can occur despite meticulous technique. In this in vivo human pilot study, we investigated the potential for detecting vascular penetration with optical reflectance spectroscopy during blocks of the sympathetic chain and the communicating ramus at lumbar levels. METHODS: A custom-designed needle stylet with integrated optical fibers was used in combination with a commercial needle shaft. The needle stylet was connected to a console that delivered broadband light to tissue and spectrally resolved light that was scattered near the stylet tip. A total of 18 insertions were performed on 10 patients; testing for vascular penetration at the nerve target region was performed with aspiration and with radio-opaque contrast injections, visualized fluoroscopically. Optical absorption by hemoglobin was quantified with a blood parameter that was calculated from each spectrum. The blood parameter provided a measure of the difference between spectra acquired from the nerve target region and reference spectra acquired from blood extracted from a volunteer. RESULTS: In 2 insertions, vascular penetration was detected. Pronounced optical absorption by hemoglobin was observed to be associated with both of these events and absent in all other cases. The difference between the blood parameters obtained when vascular penetration was detected, and all other blood parameters were statistically significant (P = 0.006), with a diagnostic odds ratio of 35.4 (confidence interval, 2.21 to ∞). CONCLUSIONS: The results from this study suggest that optical spectroscopy has the potential to detect intravascular needle placement, which may in turn increase the safety of nerve blocks.

Needle stylet with integrated optical fibers for spectroscopic contrast during peripheral nerve blocks.

The effectiveness of peripheral nerve blocks is highly dependent on the accuracy at which the needle tip is navigated to the target injection site. Even when electrical stimulation is utilized in combination with ultrasound guidance, determining the proximity of the needle tip to the target region close to the nerve can be challenging. Optical reflectance spectroscopy could provide additional information about tissues that is complementary to these navigation methods. We demonstrate a novel needle stylet for acquiring spectra from tissue at the tip of a commercial 20-gauge needle. The stylet has integrated optical fibers that deliver broadband light to tissue and receive scattered light. Two spectrometers resolve the light that is received from tissue across the wavelength range of 500-1600 nm. In our pilot study, measurements are acquired from a postmortem dissection of the brachial plexus of a swine. Clear differences are observed between spectra acquired from nerves and those acquired from adjacent tissue structures. We conclude that spectra acquired with the stylet have the potential to increase the accuracy with which peripheral nerve blocks are performed.

Optical detection of the brachial plexus for peripheral nerve blocks: an in vivo swine study.

BACKGROUND AND OBJECTIVES: Accurate identification of nerves is critical to ensure safe and effective delivery of regional anesthesia during peripheral nerve blocks. Nerve stimulation is commonly used, but it is not perfect. Even when nerve stimulation is performed in conjunction with ultrasound guidance, determining when the needle tip is at the nerve target region can be challenging. In this in vivo pilot study, we investigated whether close proximity to the brachial plexus and penetration of the axillary artery can be identified with optical reflectance spectroscopy, using a custom needle stylet with integrated optical fibers. METHODS: Ultrasound-guided insertions to place the needle tip near the brachial plexus at the axillary level were performed at multiple locations in 2 swine, with the stylet positioned in the cannula of a 20-gauge stimulation needle. During each insertion, optical reflectance spectra were acquired with the needle tip in skeletal muscle, at the surface of muscle fascia, and at the nerve target region; confirmation of the final needle position was provided by nerve stimulation. In addition, an insertion to the lumen of the axillary artery was performed in a third swine. Differences in the spectra were quantified with lipid and hemoglobin parameters that provide contrast for optical absorption by the respective chromophores. RESULTS: The transition of the needle tip from skeletal muscle to the nerve target region was associated with higher lipid parameter values (P < 0.001) and lower hemoglobin parameter values (P < 0.001). The transition of the needle tip from muscle fascia to the nerve target region was associated with higher lipid parameter values (P = 0.001). Intraluminal access of the axillary artery was associated with an elevated hemoglobin parameter. CONCLUSIONS: Spectroscopic information obtained with the optical needle is distinct from nerve stimulation and complementary to ultrasound imaging, and it could potentially allow for reliable identification of the injection site during peripheral nerve blocks.

Identification of the epidural space with optical spectroscopy: an in vivo swine study.

BACKGROUND: Accurate identification of the epidural space is critical for safe and effective epidural anesthesia or treatment of acute lumbar radicular pain with epidural steroid injections. The loss-of-resistance technique is commonly used, but it is known to be unreliable. Even when it is performed in conjunction with two-dimensional fluoroscopic guidance, determining when the needle tip enters the epidural space can be challenging. In this swine study, we investigated whether the epidural space can be identified with optical spectroscopy, using a custom needle with optical fibers integrated into the cannula. METHODS: Insertion of the needle tip into the epidural space was performed with midline and paramedian approaches in a swine. In each insertion, optical spectra were acquired at different insertion depths, and anatomical localization of the needle was determined by three-dimensional imaging with rotational C-arm computed tomography. Optical spectra that included both visible and near-infrared wavelength ranges were processed to derive estimates of the blood and lipid volume fractions. RESULTS: In all insertions, the transition of the needle tip to the epidural space from an adjacent tissue structure (interspinous ligament or the ligamentum flavum) was found to be associated with an increase in the lipid volume fraction. These increases, which ranged from 1.6- to 3.0-fold, were statistically significant (P = 0.0020). Lipid fractions obtained from the epidural space were 1.9- to 20-fold higher than those obtained from muscle (P = 0.0013). Accidental penetration of an epidural vein during one insertion coincided with a high blood volume fraction. CONCLUSIONS: The spectroscopic information obtained with the optical spinal needle is complementary to fluoroscopic images, and it could potentially allow for reliable identification of the epidural space during needle placement.