| CTRI Number |
CTRI/2022/06/043603 [Registered on: 30/06/2022] Trial Registered Prospectively |
| Last Modified On: |
27/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
A Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out the number of cases and causes of infection at intravenous cannula ( a plastic device inserted in vein to give injection) site in children admitted in AIIMS Delhi |
|
Scientific Title of Study
|
A prospective study to assess the incidence and predisposing factors of phlebitis associated with peripheral intravenous cannula in children admitted in Pediatrics wards of AIIMS, New Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAMGOPAL SHARMA |
| Designation |
MSc Nursing Student |
| Affiliation |
Collage of Nursing , AIIMS New Delhi |
| Address |
Collage of Nursing ,AIIMS New Delhi
Collage of Nursing , AIIMS New Delhi, 110029
South West
DELHI
110029
India |
| Phone |
8860901898 |
| Fax |
|
| Email |
rgsaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Cecilia MS |
| Designation |
Associate Professor |
| Affiliation |
Collage of Nursing , AIIMS New Delhi |
| Address |
Collage of Nursing ,AIIMS New Delhi
Collage of Nursing , AIIMS New Delhi.110029
South West
DELHI
110029
India |
| Phone |
9899187056 |
| Fax |
|
| Email |
cecilia.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAMGOPAL SHARMA |
| Designation |
MSc Nursing Student |
| Affiliation |
Collage of Nursing , AIIMS New Delhi |
| Address |
Collage of Nursing ,AIIMS New Delhi
Collage of Nursing , AIIMS New Delhi, 110029
South West
DELHI
110029
India |
| Phone |
8860901898 |
| Fax |
|
| Email |
rgsaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| monetary burden will be incurred by investigator only. There is no sponsor |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS New Delhi |
| 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 |
| Ramgopal Sharma |
Paediatrics ward , AIIMS new Delhi |
AIIMS, Ansari Nagar, New Delhi
South West
DELHI |
8860901898
0
rgsaiims@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS ETHICS COMMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
This study will include children who are
1-Admitted in pediatrics wards .
2-Having only one PIVC at a time.
3-Up to 12 year of age |
|
| ExclusionCriteria |
| Details |
This study will exclude children who are
1.Having PIVC inserted outside from AIIMS.
2.Under continuous sedation
3.Not willing to participate in study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sign of Phlebitis like redness, swelling at the site of peripheral intravenous cannula |
with in 5 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sign of Phlebitis like redness, swelling at the site of peripheral intravenous cannula |
at 24 hour
at 48 hour
at 72 hour
at 96 hour
at 120 hour
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2022 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Not applicable |