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Corresponding author: Govind R Rajan MD, MBBS, FAACD, FASA, Department of Anesthesiology and Perioperative Care, University of California, Irvine Medical Center, 101 The City Drive South, B53-226G, Orange CA 9286 Phone: (314) 803-9398, Fax: (714) 456-9528
To determine whether the wire-guided scalpel (GuideBlade®) improves incision precision, reduces the need to revise dermatotomy incision, improves first-time success rate of central venous catheter (CVC) placement, and decreases CVC-related complications.
Design
A randomized 2-arm observational trial
Setting
xxxxx Medical Center
Participants
Patients (n= 63) undergoing surgery requiring placement of CVC as part of standard of care recruited from August 1, 2021 to December 31, 2021
Interventions
After randomization, either the GuideBlade® (intervention) or the standard #11 scalpel (control) was used during CVC placement prior to surgery.
Measurements and Main Results
Number of dermatotomy attempts are higher using the GuideBlade® (1.6±1.0) compared to the standard #11 scalpel (1.4±0.6), however, the difference did not reach statistical significance (p=0.19). Similarly, number of dilation attempts demonstrated no significant difference between GuideBlade® (1.2±0.4) and the standard scalpel (1.1±0.4; p=0.65). No CVC-related infections or complications were documented.
Conclusions
No superiority was observed with the use of GuideBlade® compared to the standard scalpel during central line insertion in novice users. User unfamiliarity and inadequate training may have contributed to this finding, highlighting the importance of proper technique and user experience.
Central venous catheter (CVS) placement is a common procedure performed in medicine today for physiologic monitoring during surgical operations1. This procedure is generally performed using the Seldinger or modified Seldinger technique. During CVC placement, prior to introduction of the tissue dilator, a #11 scalpel is often used to make a dermatotomy incision immediately adjacent to the in-situ guidewire with the purpose of expanding entry site. Unsatisfactory or imperfect dermatotomy can lead to possible complications following CVC placement, including central line associated bloodstream infections (CLABSI) and dilator-related mechanical complications2.
GuideBlade®3 is an FDA-approved modified scalpel with a hollow channel on its underside for the in-situ vascular guidewire, thus allowing clinicians to utilize the wire to guide the dermatotomy incision during placement of CVC (Figure 1). The aim of this study is to determine whether the device reduces the need to revise or perform more than one dermatotomy incision, decrease bleeding and soft tissue trauma at the CVC insertion site, improve first-time success rate of CVC placement, and decrease CVC-related complications.
Figure 1GuideBlade® is a wire-guided scalpel with retracted safety sheath and a hollow channel sized to accommodate vascular guidewires. (a) Safety sheath locked in closed position. (b) Safety sheath retracted to open position after the guidewire is threaded through the channel
This randomized two-arm prospective, observational trial was approved by the Institutional Review Boards (IRB) board and conducted at xxxxx Medical Center between July 2021 to December 2021. Patients undergoing surgery requiring CVC placement as standard of care were included for the study. Inclusion and exclusion criteria can be found in the supplementary file. Upon obtaining written consent, patients were randomized into either the intervention group: wire-guided scalpel (GuideBlade®) or control group: standard #11 scalpel group. All CVC procedures were performed by residents supervised by attending physicians. Prior to insertion, all proceduralists were given instructions of the proper manipulation method (Procedural instructions and video provided in supplemental data). All procedures were performed using sterile technique according to established institutional protocol. The success of CVC insertions were verified by ultrasound imaging or chest radiography.
Procedure and Data Collection
During CVC placement, once the guidewire was successfully advanced and needle removed, the proceduralist used either the GuideBlade® or the standard #11 scalpel from the CVC insertion kit based on patient randomization to make the dermatotomy. A timer operated by a research team member started the moment the proceduralist received the blade. Duration between proceduralist receiving the blade for dematotomy to successful dilation with the dilator was recorded for each case. Total dermatotomy attempts, dilation attempts, catheter insertion attempts were also documented through the catheter insertion processes. Any bleeding during and immediately after CVC insertion was quantified visually by the research team member and documented. Proceduralists were interviewed to provide comments and feedback after each case.
Patient charts were reviewed post-operatively for Central-Line Insertion Site Assessment (CLISA) scores during hospitalization and review notes up to their four-to-six-week post-surgical follow-up visit to determine any CVC-related complications following discharge. Patient bleeding risks including any coagulopathy as well as usage of antiplatelet or anticoagulants in the perioperative period were recorded and categorized into five bleeding-risk groups.
Primary and secondary outcomes
Primary outcomes were number of dermatotomy incisions, number of attempts for successful dilation, number of successful catheter insertions, and the occurrence of CLABSI. Secondary exploratory outcomes were occurrence of guidewire bending, kinking, looping, or fracture during CVC placement, and patient bleeding at CVC insertion site.
Statistical analysis
T tests were performed to evaluate outcomes between patients receiving the standard and Guideblade scalpels. Due to the significant discrepancy in catheter between Percutaneous Sheath Introducer (PSI) catheters and all other types of central lines used, a subgroup analysis of PSI versus non-PSI catheter outcomes were conducted. To avoid interpersonal discrepancies as well as examine graphically whether there was any relationship between number of previous GuideBlade® experiences and performance, boxplots were created for GuideBlade® data over number of uses with the device. Statistical analysis was performed using Microsoft Exell. All effects were considered significant at p < 0.05.
Results
Patient demographics
63 patients undergoing surgery requiring placement of CVC as part of standard of care were recruited from xxxxx Medical Center from August to December 2021. Among the 63 participants, 38 were randomized to the GuideBlade® group and 25 to the standard scalpel group. 25 patients in the GuideBlade® group received two CVC placements, while 13 received a single CVC placement. In the standard scalpel group, 9 patients received two CVC placements and 16 received a single CVC placement. Baseline demographics are shown in Table 1.
Number of dermatotomy attempts are higher using the GuideBlade® (1.6±1.0) compared to the standard scalpel (1.4±0.6), however, the difference did not reach statistical significance (p=0.19). Similarly, number of dilation attempts demonstrated no significant difference between GuideBlade® (1.2±0.4) and the standard scalpel (1.1±0.4; p=0.65). The time required from the start of incision to successful dilation was significantly longer with the use of GuideBlade® (103.41±82.2) compared to the use of the standard scalpel (67.93±44.3; p=0.007).
Subgroup analysis of PSI (p=0.034) and non-PSI (p=0.037) CVC placement both similarly revealed significantly longer procedural length using GuideBlade®. All documented CLISA scores were 0 and no CVC-related infections nor complications, such as significant bleeding or poor wound healing, were reported at four-week post-op chart review.
A relationship between number of previous experiences using the GuideBlade® and time required to successful dilation was observed, as total procedure time decreased following initial use experience (Figure 1). However, this effect plateaued after 3-4 uses. Furthermore, total time remained prolonged compared to the standard scalpel.
Secondary outcomes
Among all CVC insertions, more than normal bleeding was visually appreciated in three cases. Two of the three instances were observed in the GuideBlade® group, while one occurred in the control group. There were five wires that were kinked, all of which were observed during dilation after using the GuideBlade®.
There were two isolated incidents of the proceduralist switching from GuideBlade® to the standard scalpel due to inability to produce an adequate skin incision for dilation after several attempts. During the first incident, the proceduralist was unable to break the skin with five total attempts using the GuideBlade®. They then proceeded with the use of a standard #11 scalpel. An incision was made after switching blades, but dilating was difficult, requiring two attempts with excessive force. The dilator was visibly bent after successful dilation. For the second incident, after two incision attempts, dilation was unsuccessful and led to guidewire kinking. After replacing the wire, the proceduralist switched to the standard #11 scalpel to revise the incision. They were able to successfully dilate after the third revision.
Discussion
Our results indicate no superiority of the GuideBlade® scalpel over the standard scalpel in reducing number of incisions, incidence in CVC-related complications, nor first time success rate of CVC placement. Use of the GuideBlade® scalpel significantly lengthened the amount of time placing the central line, however. This was foreseeable with the additional steps required in the manipulation of the GuideBlade® scalpel which includes passing the guidewire through the blade and unsheathing of protective sheath.
As anticipated, a user learning curve for GuideBlade® was observed with shortened overall time after initial use and confirmed by multiple user feedback stating increased comfort and confidence during manipulation. This observation highlights the impact of previous education and training on ease of use of the novel scalpel, which is a consideration for our observed results. Other comments we received were mixed with some stating subjectively improved dermatotomy and others suggesting procedural redundancy.
The percutaneous sheath introducer (PSI) catheter is commonly used in cardiac surgeries and intensive care settings. Compared to single to triple lumen CVCs, PSI contains a introducer port that allows proceduralists to introduce transvenous catheters such as the Swan Ganz catheter in addition to the infusion ports. Due to the extra introducer lumen, the PSI catheter has a significantly larger diameter and generally requires more time and a slightly different technique to insert. We observed an overall lengthier and more challenging process during PSI insertions, subgroup analyses of PSI catheter as well as non-PSI catheter placements were therefore conducted. Similar to the main analysis finding, both groups showed significantly lengthened amount of time when using the GuideBlade®. This finding was able to eliminate the possible bias from catheter diameter discrepancies resulting in procedural duration differences.
During CVC placement, guidewire kinking is often a direct result of using excessive force to push the dilator through the incision4. Inadequate dermatotomies can complicate the dilating process and lead to dilator-related mechanical injuries from using excessive force during dilation and pose safety risks to patients. However, faulty tissue dilating techniques despite adequate dermatotomy can also lead to vascular injuries and excessive bleeding4. Among all observed CVC placements in our study, wire kinking occurred in five cases. All incidents occurred in the GuideBlade® group during dilation. It is impossible to eliminate the possibility of faulty personal dilation technique and patient anatomy discrepancies leading to these events. However, after observing the procedures, we hypothesize that increased risk of wire kinking during dilation and wire damage can occur if the angle of the GuideBlade® is not parallel to the wire while making the wire-guided skin incision. The importance of proper manipulation technique should be emphasized.
In terms of bleeding, prior studies have reached contrasting conclusions5-7 for an association between abnormal coagulation, as measured by abnormal prothrombin time (PT), partial thromboplastin time (PTT), and low platelet counts, with increased bleeding risk during CVC placement. Despite conflicting evidence on the clinical impact of coagulopathy, there is an overall lack of evidence to support a causal link between abnormal coagulation values, both corrected and uncorrected prior to surgery, with increased bleeding risk in CVC insertions8. Similarly in our results, a considerable proportion of the patients were on prior anti-coagulation, anti-platelet therapy prior to surgery, or received anti-coagulation medication during the operation, but the risk of significant bleeding was low.
The unique advantage of this wire-guided scalpel is the improved precision of the incision. This quality has been mentioned by multiple users in our study. Due to the unique design of the blade, with the guidance of the wire, incision is guaranteed to be aligned and continuous to the in-situ guidewire. This precision allows for avoidance of skin tags or bridges between the needle insertion site and the incision made by the scalpel (Figure 3). However, there are also several functional drawbacks that were identified. Incisional width and depth can be difficult to assess during dermatotomy as it is affected by the angle at which the blade is introduced (Figure 4). Additionally, if the GuideBlade® is not rotated slightly during incision, the blade and guidewire can block direct visualization of the incision, leading to excessive or inadequate incisions. During our study, a second incision was common due to an inadequate incision during the first attempt. There were also three incisions that were made wider than desired due to the inability to assess depth and width. This may be due to the unfamiliarity of the device, highlighting both the underlying complexity to properly manipulate the blade and the benefits of prior experiences. We were able to identify two critical procedural points for successful incisions: (1) Holding counter-traction of the skin with the non-dominant hand during incision, and (2) angling the blade so it is not perpendicular to the plane of the skin. With proper technique and experience, users reported improved incision precision that eliminated the possibility of creating skin bridges.
The present study may hold several limitations. First, our sample number was not large enough to identify superiority of dermatotomy in regards to CVC-related complications. Second, there is no objective and direct measure to assess incision precision. Surrogates such as dermatotomy attempts and procedural time were used instead. Third, there were a few identifiable factors that could have influenced successful insertion of CVC and procedural time. These factors include insertion site, interruptions during the procedure (i.e. teaching, talking), and personal experience. Lastly, there was no standardized and comprehensive teaching for the use of the GuideBlade®. Educational information provided prior to every use was determined by clinical scenarios, curiosity of the proceduralist, and potential time restrictions in the clinical setting.
In conclusion, the GuideBlade® is a novel wire-guided scalpel that aims to create precise dermatotomies during procedures utilizing the Seldinger technique. In our study, no outcome superiority was observed with the use of Guideblade compared to the standard scalpel during central line insertion in novice users. User unfamiliarity and lack of formal training may have contributed to this finding as improved precision was observed in successful incisions. Adequate training and proper techniques are crucial for safe and effective manipulation of this novel blade.
1. Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med 2004;30(1):62-67.
4. Dubey PK. Kinking, unwinding and retrieval of the Seldinger guide wire. J Anaesthesiol Clin Pharmacol 2014;30(4):581-582.
5. Kander T, Frigyesi A, Kjeldsen-Kragh J, et al. Bleeding complications after central line insertions: relevance of pre-procedure coagulation tests and institutional transfusion policy. Acta Anaesthesiol Scand 2013;57(5):573-579.
6. Zeidler K, Arn K, Senn O, et al. Optimal preprocedural platelet transfusion threshold for central venous catheter insertions in patients with thrombocytopenia. Transfusion 2011;51(11):2269-2276.
7. Björkander M, Bentzer P, Schött U, et al. Mechanical complications of central venous catheter insertions: A retrospective multicenter study of incidence and risks. Acta Anaesthesiol Scand 2019;63(1):61-68.
8. van de Weerdt EK, Biemond BJ, Baake B, et al. Central venous catheter placement in coagulopathic patients: risk factors and incidence of bleeding complications. Transfusion 2017;57(10):2512-2525.
GuideBlade® used in the study were supplied by Ambitus Medical Supplies LLC. This research otherwise did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. No other competing interests to declare.
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