A study to evaluate the ability and also to assess the risks of Intravenous line Organizer in patients admitted in speciality wards of General Hospitals.

Completed

• Conditions: New Technology,

• Registration Number: CTRI/2023/01/049072
• Lead Sponsor: Derryl Burke

Brief Summary

This is an open labeled, randomized, controlled clinical study to study the performance and safety of Intravenous Line Organizer in patients admitted to tertiary teaching hospital. The objective is to assess the performance and safety of those patients with and without Intravenous line Organizer in patients admitted to medicine and paediatric wards and determine the perception of Physician, Nurses, patients and patients caregiver on effectiveness of the device. Device Usability questionnaire on subject’s perception, patients autonomy, mobility and comfort will be assessed by Global scale, ease of operability scale, Severity of Intravenous Line Entanglement, skin irritation and AE,SAE were assessed.

The assessment will be done during visit 2 (treatment phase) and During visit 3 (end of visit). The result of the study will be summarized with summary statistics including average and standard deviation (SD) for continuous variable and frequency and percentages for categorical variables.

Any AEs will be summarized with a number and the percentage.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-20
• Study Completion: 2023-06-02
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Emergency rooms for patient hydration line (Glucose), Haematology, Pediatrics up to 18 years, Operations (OR) I.C.U. (Intensive Care Units) From simple to complicated.

Exclusion Criteria

• 1.Skin allergy 2.Skin burns 3.
• Pregnant and lactating women 4.
• Psychiatric illness patients 5.
• Severe illness patients 6.
• Not willing to obtain informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the greater autonomy, mobility and comfort using a global scale (0-4 scale where 0- no mobility and 4- highest mobility) by a physician, nurse and patient or patient care giver	Visit 1 (Baseline) | Visit 2 (During the study) | Visit 3 (End of the study)

Secondary Outcome Measures

Name	Time	Method
To assess the Device Usability questionnaire on subject’s perception by nurse and patient or patient care giver	End of study
To assess the skin irritation	Start to End of study
.To assess the adverse events	Start to End of study
To assess the ease of operability and set up by a physician, nurse and patient or patient care giver (0- Not easy and 4- Very Easy)	Start to end of study
To assess the Severity of Intravenous Line	Entanglement by Medical Line Entanglement scale by a physician, nurse and patient or patient care giver

Trial Locations

Locations (1)

Sapthagiri Institute of Medical Sciences and Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Sapthagiri Institute of Medical Sciences and Research Centre

🇮🇳Bangalore, KARNATAKA, India

Dr Renuka Venkatesh

Principal investigator

9482079621

renu_70s@yahoo.co.in