Self-reported MeasUrement of Physical and PsychosOcial Symptoms Response Tool (SUPPORT-dialysis): systematic symptom assessment and management in patients on in-centre haemodialysis - a parallel arm, non-randomised feasibility pilot study protocol.

INTRODUCTION: Patients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment, using electronic patient reported outcomes measure (ePROMs) linked to systematic symptom management, could improve such outcomes. Clinical implementation of ePROMs have been successful in routine oncology care, but not used for patients on dialysis. In this study, we describe a pilot study of ePROM-based systematic symptom monitoring and management intervention in patients treated with in-centre haemodialysis. METHODS AND ANALYSIS: This is a parallel-arm, controlled pilot of adult patients receiving in-centre maintenance haemodialysis. Participants in the intervention arm will complete ePROMs once a month for 6 months. ePROMs will be scored real time and the results will be shared with participants and with the clinical team. Moderate-severe symptoms will be flagged using established cut-off scores. Referral options for those symptoms will be shared with the clinical team, and additional symptom management resources will also be provided for both participants and clinicians. Participants in the control arm will be recruited at a different dialysis unit, to prevent contamination. They will receive usual care, except that they will complete ePROMs without the presentation of results to participants of the clinical team. The primary objectives of the pilot are to assess (1) the feasibility of a larger, randomised clinical effectiveness trial and (2) the acceptability of the intervention. Interviews conducted with participants and staff will be assessed using a content analysis approach. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the University Health Network (REB#21-5199) and the William Osler Health System (#23-0005). All study procedures will be conducted in accordance with the standards of University Health Network research ethics board and with the 1964 Helsinki declaration and its later amendments. Results of this study will be shared with participants, patients on dialysis and other stakeholders using lay language summaries, oral presentations to patients and nephrology professionals. We will also be publishing the results in a peer-reviewed journal and at scientific meetings. PROTOCOL VERSION: 4 (16 November 2022). TRIAL REGISTRATION NUMBER: NCT05515991.

Randomized pilot study to compare metal needles versus plastic cannulae in the development of complications in hemodialysis access.

BACKGROUND: Hemodialysis requires needle insertions every treatment. Needle injury (mechanical or hemodynamic) may cause complications (aneurysms/stenosis) that compromise dialysis delivery requiring interventions. Metal needles have a sharp slanted "V"-shaped cutting tip; plastic cannulae have a dull round tip and four side holes. Preliminary observations demonstrated a difference in intradialytic blood flow images and mean Doppler velocities at cannulation sites between the two devices. Complications from mechanical and hemodynamic trauma requiring interventions were compared in each group. MATERIALS AND METHODS: In all, 33 patients (13 females and 17 new accesses) were randomized to metal group (n = 17) and plastic group (n = 16). Mechanical trauma was minimized by having five nurses performing ultrasound-guided cannulations. Complications were identified by the clinician and addressed by the interventionalists, both blinded to study participation. Patients were followed for up to 12 months. RESULTS: Baseline characteristics were not significant. Procedures to treat complications along cannulation segments increased from 0.41 to 1.29 per patient (metal group) and decreased from 1.25 to 0.69 per patient (plastic group; p = 0.004). The relative risks of having an intervention (relative risk = 1.5, 95% confidence interval = 0.88-2.67) and having an infiltration during hemodialysis (relative risk = 2.26, 95% confidence interval = 1.03-4.97) were higher for metal needles. Time to first intervention trended in favor of plastic cannula (p = 0.069). Cost of supplies for these interventions was approximately CAD$20,000 lower for the plastic group. CONCLUSION: Decreased burden of illness related to cannulation (less infiltrations during hemodialysis) and Qb were associated with plastic cannulae. Decreased procedure costs were suggested during the study period in the plastic group.

Impact of needles in vascular access for hemodialysis.

This article reviews pragmatic aspects of cannulation practice and types of cannulation devices, as well as their impact in vascular access for hemodialysis. Hemodialysis treatment requires successful insertion of two needles for each dialysis treatment. The first needle is the arterial needle; it removes blood with toxin accumulation from the patient and delivers it to the dialysis machine. The second needle, called the venous needle, returns the purified blood from the dialyzer to the patient. Mechanical and hemodynamic trauma related to needle insertions will be discussed.

Development of competencies for the use of bedside ultrasound for assessment and cannulation of hemodialysis vascular access.

Use of ultrasound for hemodialysis vascular access assessment and real-time cannulation requires specialized training. In order to obtain basic hand-eye coordination, theoretical sessions on ultrasound use, as well as practical sessions using phantom models are recommended prior to its use in the clinical setting with patients. New users of this technology need to consider that all competencies can be achieved with daily use of ultrasound at the bedside. It takes approximately 500 guided cannulations to achieve the highest level of competency described above.

Supercath Safety Clampcath buttonhole creation: complication of catheter breakage.

The creation of buttonhole tracks with Supercath Safety Clampcath is a novel and simple technique that allows dull fistula needle insertions with relative ease and diminished pain. As greater experience with this procedure develops, new issues arise for consideration. We report an unexpected complication of Supercath Safety Clampcath catheter breakage that may be due to physical distortions as a result of its location in the antecubital fossa just proximal to the elbow joint. We present a review of our experience and a framework for the safe ongoing use of this device for creation of buttonholes in fistula for hemodialysis.

When is a new fistula mature? The emerging science of fistula cannulation.

Once an arteriovenous fistula is established, the blood vessels are subjected to marked changes in hemodynamic forces that trigger remodeling to re-establish baseline parameters of sheer and hoop stress. These homeostatic processes culminate in two requirements that define an adequate and enduring access. First, blood flow must increase to provide amounts that will provide adequate delivery of blood to the artificial kidney. Second, the vessel wall must undergo changes that will allow it to withstand repeated cannulation. Hence, a fistula is mature when it can do what it sets out to do (flow readiness) despite what is being done to it (cannulation readiness). Although flow has been measured with Doppler, high-frequency ultrasound is needed to measure vessel wall thickness to determine hoop stress. Beyond the wall of the vessel, the concept of cannulation readiness depends on the skill and expertise of the cannulator.

Arteriovenous fistulas for hemodialysis: application of high-frequency US to assess vein wall morphology for cannulation readiness.

PURPOSE: To determine whether venous wall thickness and hoop (circumferential) stress, as determined with high-frequency ultrasonography (US), can predict cannulation readiness in arteriovenous fistulas (AVFs). MATERIALS AND METHODS: Institutional review board approval and informed consent were obtained for this prospective study. To determine the US appearance of the venous wall, an AVF specimen was excised and scanned in a bath of degassed lactated Ringer solution with a 55-MHz probe. The appearance of the wall at high-frequency US was correlated with histologic findings. High-frequency (40-55-MHz) US was used to image the near-field AVF venous wall of 14 men (mean age, 59 years ± 11 [standard deviation]) and six women (mean age, 55 years ± 14) with newly created AVFs within 1 week of cannulation between January 2008 and December 2009. Measurements of the intima-media thickness (IMT) were generated by three independent observers who were blinded to outcomes. Intraclass correlation analysis was performed. Cannulation readiness was defined as no extravasation during the first dialysis treatment. RESULTS: By using high-frequency US, the IMT was defined as the sum of a thin echogenic blood-intima interface and a uniform hypoechoic media. The mean IMT of the no extravasation group (0.16 mm ± 0.03) was greater than that of the extravasation group (0.10 mm ± 0.02) (P < .001). A minimum threshold IMT of 0.13 mm (P < .001) was associated with successful cannulation. The mean hoop stress of the no extravasation group (246 kPa ± 57) was lower than that of the extravasation group (530 kPa ± 199) (P < .001). A maximum hoop stress threshold of 248 kPa was associated with successful cannulation (P = .009). CONCLUSION: Venous IMT and hoop stress assessed with high-frequency US can predict cannulation readiness in AVFs that are clinically deemed mature.

Use of the BioHole™ device for the creation of tunnel tracks for buttonhole cannulation of fistula for hemodialysis.

Buttonhole cannulation is a method of cannulation of native arteriovenous fistulae traditionally practiced by self-cannulators. At St Michael's Hospital, this method has been modified to allow its use in problematic fistulae by multiple cannulators. In a busy dialysis unit, the need for a few specific cannulators to establish the tunnel tracks in combination with the variable dialysis schedules creates logistical challenges. A new method of creating tunnel tracks with the use of the BioHole™ device was evaluated. Buttonhole tracks were created in 12 patients using a peg of polycarbonated material with a holder (BioHole™ kit). The peg was inserted into the path left by the hemodialysis sharp needle following the index cannulation. Four of the 12 patients had an alternate access. Buttonhole tracks were successfully created in all the patients, albeit in 2 patients, the initial attempt to establish buttonhole tracks was aborted due to complications and the procedure was rescheduled. Compared with the modified buttonhole technique, pain on cannulation following track creation was significantly less in the BioHole™ group (P < 0.001). Ease of cannulation was significantly improved in the BioHole™ group (P<0.05) when compared with that in thrice-weekly patients using the modified buttonhole technique. Hemostasis postdialysis did not differ between the study groups. The use of the BioHole™ device is effective in the creation of tunnel tracks for buttonhole cannulation, is associated with less pain, and simplifies the logistics of arranging patient and nurses' schedules.

A simple method to create buttonhole cannulation tracks in a busy hemodialysis unit.

The preference for fistulae as the hemodialysis access of choice has led to a significant number of accesses that are less than ideal for cannulation. Buttonhole cannulation is ideal for such accesses, but the technique for creation provides major challenges. In 12 patients, buttonhole tunnel tracks were created by leaving the polyurethane catheter of a Clampcath hemodialysis needle indwelling for 10 days after the initial cannulation. After each dialysis the catheter was flushed, and dressed with an antibacterial ointment and gauze. Dialysis was carried out via the catheter during that time. After day 10, the catheter was removed, the tunnel track covered with an antibacterial dressing and the tunnel track was cannulated with a dull buttonhole needle at the next dialysis. Successful buttonhole accesses were created in 11 patients after 10 days, the 12th patient required a single sharp needle cannulation before using dull needles. During the first 2 weeks of dull needle cannulation both pain experienced on cannulation and the difficulty cannulating the access were significantly less than in the classical buttonhole technique (P<0.01). Complications during the follow-up period (6 months-1.5 years) included difficulty cannulating with a dull needle (22) and antibacterial agent induced contact dermatitis (4). There was no episode of sepsis or tunnel track infection. Initial cannulation of the fistula using a Clampcath hemodialysis needle, leaving the polyurethane catheter indwelling for 10 days, is a simple, safe, and effective technique for the creation of buttonhole tunnel tracks.

The salvage of aneurysmal fistulae utilizing a modified buttonhole cannulation technique and multiple cannulators.

We describe the St Michael's Hospital (SMH) modified buttonhole (BH) cannulation technique as a method that offers a solution for fistulae with aneurysmal dilatation due to repetitive cannulation in a restricted area. This is a prospective cohort study of 14 chronic hemodialysis (HD) patients with problematic fistulae (marked aneurysmal formation and thinning of the overlying skin, bleeding during treatment, and prolonged hemostasis post-HD) because of repetitive, localized cannulation. Each patient was followed for 12 months. The protocol was as follows: creation of tunnel tracks by 1 to 3 experienced cannulators per patient, using sharp needles. After the tunnel tracks were established and cannulation was easily achieved with dull needles, additional cannulators were incorporated with the guidance of a mentor. Bleeding from cannulation sites during dialysis ceased within 2 weeks and skin damage resolved within 6 months in all patients. Hemostasis time postdialysis decreased from 24 to 15 min. Cannulation pain scores decreased significantly. Access flows and dynamic venous pressure measurements remained unchanged. No interventions were required to maintain access patency. In 2 cases, the aneurysms became much less evident. Complications included one episode of septic arthritis and one contact dermatitis. A third patient developed acute bacterial endocarditis 9 months following completion of her follow-up. The SMH modified BH cannulation technique can salvage problematic fistulae, prevent further damage, and induce healing of the skin in the areas of repetitive cannulation. This technique can be successfully achieved by multiple cannulators in a busy full-care HD unit.