| CTRI Number |
CTRI/2025/07/090321 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Functional Durability of Peripheral Intravenous Cannula with Attached Three-way Stopcock Without Extension Tubing and With 10 cm Extension Tubing in Children |
|
Scientific Title of Study
|
Functional Durability of Peripheral Intravenous Cannula with Attached Three-way Stopcock Without Extension Tubing and With 10 cm Extension Tubing in Children – A Randomized Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VEMULA ABHINAY |
| Designation |
Junior resident |
| Affiliation |
AIIMS MANGALAGIRI, central institute |
| Address |
Department of pediatrics, AIIMS Mangalagiri, Guntur, Andhrapradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9866207371 |
| Fax |
|
| Email |
abhinayvemula1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DIPTIREKHA SATAPATHY |
| Designation |
Assistant professor |
| Affiliation |
AIIMS MANGALAGIRI, Central institute |
| Address |
Department of pediatrics, AIIMS Mangalagiri, Guntur, Andhrapradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8518887314 |
| Fax |
|
| Email |
diptirekha.satapathy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VEMULA ABHINAY |
| Designation |
Junior resident |
| Affiliation |
AIIMS Mangalagiri, central institute |
| Address |
Department of pediatrics, AIIMS Mangalagiri, Guntur, Andhrapradesh
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9866207371 |
| Fax |
|
| Email |
abhinayvemula1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS MANGALAGIRI, Guntur, Andhrapradesh, 522503 |
|
|
Primary Sponsor
|
| Name |
VEMULA ABHINAY |
| Address |
DEPARTMENT OF PEDIATRICS, AIIMS MANGALAGIRI, GUNTUR, ANDHRAPRADESH, 522503 |
| Type of Sponsor |
Other [Principle investigator] |
|
|
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 |
| Vemula Abhinay |
AIIMS Mangalagiri |
Department of paediatrics, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH |
9866207371
abhinayvemula1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee, All India Institute of Medical sciences, Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extension tube |
Three-way stopcock with 10cm extension tubing |
| Comparator Agent |
no extension |
Three way stopcock without extension tube |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1month to 14 years requiring PIVC for more than 24 hours. |
|
| ExclusionCriteria |
| Details |
Pre-existing thrombophlebitis, infection or burn at local site
Patients with coagulopathy or on anticoagulants
If PIVC is needed for less than 24 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional durability of the PIVCs in each age group |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The incidence rates of thrombophlebitis & its grading
•Incidence of other complications like occlusion, extravasation & local infection
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="640"
Sample Size from India="640"
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 4 |
|
Date of First Enrollment (India)
|
03/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Peripheral intravenous catheter (PIVC) insertion is a common invasive procedure performed in up to 80 percent of hospitalized patients for the administration of fluids, medications, and blood products. Despite their utility, PIVCs have a high failure rate ranging from 35 to 50 percent, influenced by various factors including chemical (irritant drugs), mechanical (catheter size, material, location, and insertion technique), infection-related (skin flora migration or contaminated hub), and patient-specific factors (age, existing infections). Complications such as thrombophlebitis, extravasation, and occlusion contribute significantly to PIVC failure. Frequent PIVC changes depletes health care resources and gives additional risk. To improve functionality and reduce risks, 3-way stopcocks and various extension sets are used to deliver multiple infusions through a single site. Extension tubing enhances access, reduces contamination, and supports patient comfort, although it may pose risks like residual drugs and dislodgement. By maintaining a closed system and minimizing line manipulation, extensions potentially decrease complications and resource use. But till now, very limited number of studies are available that compare the functional durability (Dwell time) of different types of iv extensions. This research will compare the Durability of two types of three-way stopcocks, i.e., stopcock without any 10 cm extension tubing and that with a 10 cm extension tubing. The research data from this study will serve as critical knowledge that healthcare providers can use to create better IV therapy guidelines and improve patient care quality. |