| CTRI Number |
CTRI/2025/03/082857 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An intervention trial to reduce venous cannulation associated thrombophlebitis |
|
Scientific Title of Study
|
Reduction of Incidence of venous cannulation associated thrombophlebitis among patients admitted in wards in PDHNH A randomized clinical trial of five different interventions |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenu Jain |
| Designation |
Assistant Director Nursing |
| Affiliation |
P D Hinduja Hospital and Medical Research Centre |
| Address |
Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre Veer Savarkar Marg Mahim Mumbai
Mumbai
MAHARASHTRA
400016
India
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9833580037 |
| Fax |
|
| Email |
meenurishijain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenu Jain |
| Designation |
Assistant Director Nursing |
| Affiliation |
P D Hinduja Hospital and Medical Research Centre |
| Address |
Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre Veer Savarkar Marg Mahim Mumbai
Mumbai
MAHARASHTRA
400016
India
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9833580037 |
| Fax |
|
| Email |
meenurishijain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenu Jain |
| Designation |
Assistant Director Nursing |
| Affiliation |
P D Hinduja Hospital and Medical Research Centre |
| Address |
Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre Veer Savarkar Marg Mahim Mumbai
Mumbai
MAHARASHTRA
400016
India
Mumbai
MAHARASHTRA
400016
India |
| Phone |
9833580037 |
| Fax |
|
| Email |
meenurishijain@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre Veer Savarkar Marg Mahim Mumbai 400016 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
P D Hinduja Hospital and Medical Research Centre |
| Address |
P D Hinduja Hospital and Medical Research Centre Veer Savarkar Marg Mahim
Mumbai
MAHARASHTRA
400016
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Meenu Jain |
P D Hinduja Hospital and Medical Research Centre |
Nursing Department floor 11 West Block P D Hinduja Hospital and Medical Research Centre Veer Savarkar Marg Mahim Mumbai 400016 Maharashtra India
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9833580037
meenurishijain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee P D Hinduja Hospital and Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R229||Localized swelling, mass and lump,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Frequency of checking outcome is every 8 hours The intervention will be carried out for 10 months |
On a daily basis the assigned nurse in the ward will assess your peripheral cannula site at an interval of every 8 hours that is once in each shift from the day of insertion to the day of discontinuation of intravenous treatment therapy or removal of the peripheral cannula
The coinvestigator will capture the finding of your assessment recorded by the assigned nurse in your medical records
|
| Intervention |
Group B Frequency of checking outcome is every 8 hours The intervention will be carried out for 10 months |
On a daily basis the assigned nurse in the ward will assess your peripheral cannula site at an interval of every 8 hours that is once in each shift from the day of insertion to day of discontinuation of intravenous treatment therapy or removal of peripheral cannula and along with that nurse will also apply a splint A device used to keep a part of the body Immobilize and support it
The coinvestigator will observe the device and simultaneously capture the finding of your assessment recorded by the assigned nurse in your medical records
|
| Intervention |
Group C Frequency of checking outcome is every 8 hours The intervention will be carried out for 10 months |
On a daily basis the assigned nurse in the ward will assess your peripheral cannula site at an interval of every 8 hours that is once in each shift from the day of insertion to day of discontinuation of intravenous treatment therapy or removal of peripheral cannula and along with that the nurse will flush your peripheral cannula with point 9 percent saline before and after nurse administer any medication through the cannula
The coinvestigator will capture the record of your pharmacy indent along with the details of intravenous medication from your medical records
|
| Intervention |
Group D Frequency of checking outcome is every 8 hours The intervention will be carried out for 10 months |
On a daily basis the assigned nurse in the ward will assess your peripheral cannula site at an interval of every 8 hours that is once in each shift from the day of insertion to day of discontinuation of intravenous treatment therapy or removal of peripheral cannula and along with that the nurse will also apply a gel like ointment that is thrombophobe Heparin 200IU plus ethanol 95 percent IP point 5g plus aqueous base a finger away from the peripheral cannula adhesive in the direction of venous flow twice a day in morning & night from the day of insertion to the day of removal of the peripheral cannula or till your discharge
The coinvestigator will observe your peripheral cannula in each shift and also capture the record of your assessment finding of the peripheral cannula recorded by the assigned nurse in your medical record
|
| Comparator Agent |
Group E Frequency of checking outcome is every 8 hours The control group assessment will be carried out for 10 months |
On a daily basis the assigned nurse in the ward will assess your peripheral cannula site once in 24 hour as per standard of care that is once in a day from the day of insertion to the day of discontinuation of intravenous treatment therapy or removal of the peripheral cannula
The coinvestigator will capture the finding of your assessment recorded by the assigned nurse in your medical records |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having peripheral venous cannulation access for treatment therapy
2 patient admitted and staying for more than 24 hours
|
|
| ExclusionCriteria |
| Details |
Patients below 18 years of age
Patient availing services in OPD A & E Day care and OT facility
Patient admitted in any location other than the study wards
Patient having peripheral line at the time of admission |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the incidence of thrombophlebitis |
every 8 hours until removal of cannula |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| severity of thrombophlebitis |
every 8 hours until removal of cannula |
|
|
Target Sample Size
|
Total Sample Size="1230"
Sample Size from India="1230"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
14/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response (Others) - document requested
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [meenurishijain@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 31-12-2030?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Peripheral IV catheterization (PIC) is the most common invasive procedure performed on hospitalized patients Phlebitis is an inflammation of the vein, which may bring with it pain, redness, swelling, hardening and/or a palpable thread by inflammation to the vein at a cannula access site. Phlebitis leads to increased discomfort for patients, longer hospital stays, and higher healthcare costs Peripheral intravenous catheters (PIVCs) are required in almost 70% of patients hospitalised in acute cate sellings for vital medical therapies such as intravenous (IV) fluids and electrolytes, antibiotics, pain relief chemotherapy blood transfusions and nutrition implementation of different interventions is expected to reduce the incidence & severity of thrombophlebitis in patients admitted in wards and receiving intravenous therapy for treatment. Comparative results from five interventions might help to decide the appropriate policy for the hospital |