An Open-Labeled, Randomized Clinical Trial to Study the Performance and Safety of an Intravenous Line Organizer (IVO) in a Tertiary Care Hospital

Background: Medical line and tube entanglement poses a significant threat causing unintentional consequences to the patients. Objectives: To study the clinical performance and safety of the IVO (intravenous line organizer) for providing patient autonomy, mobility, and comfort. Methods: Patients aged <18 years (pediatrics) and >18 years (adults) who were admitted to the hospital for treatment were included in the study. Tools like the Global Scale, Ease of Operability Scale, Severity of Intravenous Line Entanglement by Medical Line Entanglement Scale, Subjective Presumption Questionnaire, and Skin Irritation Scale, and adverse and serious adverse events were assessed and analyzed. Results: A total of 120 subjects who participated in the study were randomized into Groups-A (with IVO) and B (without IVO). The majority of patients in Group-A demonstrated better autonomy toward lines and tubes compared to Group-B in both adult and pediatric populations (86.3% vs 20%: Pediatric, 83.3% vs 26.6%: Adult), p<0.0001. Also, on mobility the Group-A patients reported improved movements with reduced restriction compared to Group-B (76.3% vs 26.6%, p<0.0001). Further, on the design and usability of IVO, 73.3% of patients in Group-A showed greater interest in the operability and usability compared to 27% in Group-B. No entanglement was reported in Group-A compared to the 12 (10%) patients facing potential harm of levels 2 & 3 who were in the standard-of-care group (without IVO). No significant adverse events were reported in patients using IVO. Conclusion: The IVO provided patients with the safe organization of intravenous tubes with greater autonomy, mobility, and comfort in managing the IV lines. Keywords: Intravenous Line Organizer, Autonomy, Mobility, Comfort, Entanglement