Vascular access devices
Conditions
Interventions
This is a pilot, randomized, controlled clinical trial with three parallel arms, conducted in an intensive care unit, aiming to evaluate the feasibility and preliminary effectiveness of different sutu
intervention group 1, in which a subcutaneous anchoring securement device will be used
and intervention group 2, in which a cyanoacrylate tissue adhesive will be used. The randomization process will be performed using pre-generated allocation lists based on permuted block randomization
however, microbiological and statistical analyses will be performed by blinded researchers, who will receive previously coded data without group identification. Participants will be followed daily for
Sponsors
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older; both sexes; clinical indication for scheduled insertion of a Peripherally Inserted Central Catheter in the upper limbs, either at admission or during the Intensive Care Unit stay; and adequate venous diameter to safely accommodate a 4 or 5 French catheter
Exclusion criteria
Exclusion criteria: Patiens with chronic kidney disease, to preserve the venous network in patients with potential future need for renal replacement therapy via arteriovenous fistula; patients with clinical conditions compromising the integrity of the skin or subcutaneous tissue in the selected limb, including extensive, infectious, or adjacent scar lesions (for example: second-degree or higher burns, active skin infections, extensive scars); catheter insertion feasible only in the antecubital fossa or forearm veins, as these sites are not recommended as preferred sites for peripherally inserted central catheter insertion according to current international guidelines; known history of hypersensitivity or allergy to any of the materials or devices used in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the occurrence of peripherally inserted central catheter dislodgement, measured as the change in external catheter length in centimeters compared with the initial measurement after fixation, classified as partial when there is an increase of greater than or equal to one centimeter in external length and as total when there is complete catheter exteriorization, with documentation based on external measurements and imaging, assessed daily throughout the entire catheter dwell time | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the occurrence of phlebitis associated with peripherally inserted central catheter, defined by the presence of local clinical signs such as pain, erythema, edema, warmth, or induration along the venous tract, graded from 0 to 4 according to the severity of signs and symptoms, with standardized clinical assessment and daily recording from catheter insertion until planned or unplanned removal, or end of follow-up;To evaluate the occurrence of catheter-associated skin injury related to peripherally inserted central catheter, defined as any alteration in skin integrity at the device or dressing site, including but not limited to erythema, vesicle, bulla, erosion, skin tear, or other cutaneous abnormalities, that persists for 30 minutes or more after removal of the dressing or securement device or requires clinical intervention, classified according to type as medical adhesive-related skin injury, insertion site infection associated with the catheter, traumatic injury including laceration, skin tear or clinically significant ecchymosis, and pressure injury associated with the catheter or securement device, with documentation of the maximum pressure injury stage when present, with standardized clinical assessment and daily recording from catheter insertion until catheter removal or end of follow-up;To evaluate the occurrence and intensity of pain associated with peripherally inserted central catheter, measured using a numeric rating scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain, as reported by the patient at the catheter insertion site at rest, during maintenance, during dressing changes, and during securement device replacement or removal, with standardized assessment and daily recording from catheter insertion until planned or unplanned catheter removal or end of follow-up;To evaluate the occurrence of adverse events associated with peripherally inserted central catheter, defined as any undesirable clinical signs, s | — |
Countries
BR
Contacts
Public ContactLetícia Vieira
Escola de Enfermagem de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed