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

Year: 2024; Volume: 4; Issue: 4; Page No: 3 – 15

Article Type:  Original Article

Authors: Baburao Vikram^1*, Renuka Venkatesh², Shruthi Shetty³, Priyanka DS⁴, Saveen Kumar S⁵, Derryl Burke^*6

https://doi.org/10.55349/ijmsnr.202444315

Affiliations:  ^*1Director, Pharexcel Consulting Private Limited, Tata New Haven, Seshagirirao Palya Village, Dasanpura Hobli, Bengaluru North Taluka, Karnataka, India.  Email ID: info@pharexcelconsulting.com

²Professor & HOD, Department of Community Medicine, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Chikkabanavara, Bengaluru, Karnataka, India. Email ID: renu_70s@yahoo.co.in

³Associate Professor, Department of Community Medicine, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Chikkabanavara, , Karnataka, India.  Email ID: drshruthis2020@gmail.com

⁴Assistant Professor, Department of Community Medicine, Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Chikkabanavara, Bengaluru, Karnataka, India.  Email ID: drpriyankamahesh1990@gmail.com

⁵Annamalai University, Annamalai Nagar, Chidambaram, Tamil Nadu India.  Email ID: saveenkumar2110@gmail.com

⁶Independent Researcher, Mine Road, Bolton East, Quebec J0E IG0, Canada.  Email ID: readaround@hotmail.com

Article Summary:  Submitted: 07-October-2024   Revised: 28-November-2024   Accepted: 12-December-2024    Published: 30-December -2024

Abstract

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

Source of funding: None

Conflict of Interest: Nothing declared by the authors

Corresponding Author:

Mr. Derryl Burke,

Independent Researcher,

68, Mine Road,

Bolton East, Quebec J0E IG0,

Canada.

Email ID: readaround@hotmail.com

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