| CTRI Number |
CTRI/2023/01/049072 [Registered on: 18/01/2023] Trial Registered Prospectively |
| Last Modified On: |
10/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
An open labelled, randomized, controlled clinical trial to study the performance and safety of Intravenous line Organizer in patients admitted to tertiary teaching hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DERYL/ILO/2022/09; Version Date: 01 Dated 18/12/22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Renuka Venkatesh |
| Designation |
Professor and HOD Department of Community Medicine |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
15, Hesarghatta Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9482079621 |
| Fax |
|
| Email |
renu_70s@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruthi M Shetty |
| Designation |
Assistant professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research |
| Address |
15, Hesarghatta Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9741734968 |
| Fax |
|
| Email |
pahuli2124@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Baburao Vikram |
| Designation |
Director |
| Affiliation |
Pharexcel Consulting Private Limited |
| Address |
11,10th Cross, AYR Layout, Shettyhalli, Jalahalli West, Bengaluru.
Bangalore
KARNATAKA
560015
India |
| Phone |
9878551428 |
| Fax |
|
| Email |
info@pharexcelconsulting.com |
|
|
Source of Monetary or Material Support
|
| Derryl Burke, 9019-8144,
Qubec Inc (of Cinemaria inc.),
68 Mine Road, Bolton East,
Qubec J0EIG0
Canada. |
|
|
Primary Sponsor
|
| Name |
Derryl Burke |
| Address |
9019-8144,
Qubec Inc (of Cinemaria inc.),
68 Mine Road, Bolton East,
Qubec J0EIG0
Canada.
|
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Renuka Venkatesh |
Sapthagiri Institute of Medical Sciences and Research Centre |
No 15, Chikkasandra, Hesaraghatta Main Road, Bangalore- 560090
Bangalore
KARNATAKA |
9482079621
renu_70s@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of Medical Sciences and Research Centre, Institutional Ethics Committee No 15, Chikkasandra, Hesaraghatta Main Road Bangalore- 560090 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous line Organizer |
An intravenous line organizing system will be attached to patients forearm or wrist. to organize one or several IV lines, preventing entanglement and contamination by dragging on the floor, while allowing patient mobility |
| Comparator Agent |
Standard of care |
Standard of care with out the Intravenous line organizer preventing entanglement and contamination by dragging on the floor, while allowing patient mobility |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| 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 |
Start to End of the study |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2023 |
| Date of Study Completion (India) |
06/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
|