CTRI Number |
CTRI/2022/07/043720 [Registered on: 05/07/2022] Trial Registered Prospectively |
Last Modified On: |
24/06/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Medical Device |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
See how the central venous catheter bundle, which is comprises of training, SOPs and ultrasonic vein locator, affects the quality of like of a childhood cancer patients. |
Scientific Title of Study
|
Measure the impact of CVC (Central Venous Catheter) Bundle on care of childhood cancer patients in India |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Amitabh Singh |
Designation |
Associate Professor Department of pediatrics |
Affiliation |
VMMC and Safdarjung Hospital |
Address |
Ansari Nagar East near AIIMS Metro Station New Delhi Delhi
New Delhi DELHI 110029 India |
Phone |
8447594629 |
Fax |
|
Email |
doc.amitabh@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Amitabh Singh |
Designation |
Associate Professor Department of pediatrics |
Affiliation |
VMMC and Safdarjung Hospital |
Address |
Ansari Nagar East near AIIMS Metro Station New Delhi Delhi
New Delhi DELHI 110029 India |
Phone |
8447594629 |
Fax |
|
Email |
doc.amitabh@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Amitabh Singh |
Designation |
Associate Professor Department of pediatrics |
Affiliation |
VMMC and Safdarjung Hospital |
Address |
Ansari Nagar East near AIIMS Metro Station New Delhi Delhi
New Delhi DELHI 110029 India |
Phone |
8447594629 |
Fax |
|
Email |
doc.amitabh@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Cankids Kidscan |
Address |
D7 7 Paschimi Marg Block D, Vasant Vihar New Delhi Delhi |
Type of Sponsor |
Other [Non Government Organization] |
|
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 Amitabh Singh |
Safdarjung Hospital |
H block, ward-21, 3rd Floor Ansari Nagar East near to AIIMS Metro Station New Delhi Delhi 110029 New Delhi DELHI |
8447594629
doc.amitabh@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee Safdarjung Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Central Venous Bundle (Traing, SOPs and Ultrasonic device for IV access) |
The CVC bundle comprises of the following:
1. Equipment – All the equipment required for venous access including central venous catheter (mainly PICC lines) and all other related consumables. This may already be available through hospital resources or may need to be provided.
2. SOPs - SOPs for insertion and care of CVC and other VAD are developed.
3. Staff – One to two dedicated staff shall be identified as the core team to learn to insert CVC at each participating center. Where the dedicated staff is not available, staff shall be provided.
4. Training – Training of the dedicated staff responsible for inserting CVC and also for all those staff involved in looking after CVC and other VAD in childhood cancer patients.
5. USG locator - This Ultrasound guidance device which will help to access veins for pediatric cancer patients with safety and high success rate will be used for CVC placement. Cankids shall arrange to provide the same to each participating centre. |
|
Inclusion Criteria
|
Age From |
0.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
a. Require IV drugs on a regular basis for 4 weeks or more during treatment in the participating center.
b. Consent to participate
|
|
ExclusionCriteria |
Details |
a. Moribund and likely failure due to anatomical variation will be excluded from the study.
b. Patients who have got multiple failures attempts previously or have a history of failed attempts for IV access.
c. Patients who have got their IV access done at other than the participating center.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
a. % CVC insertions of all VAD insertions
b. % VAD removed in 24 hours, 48 hours, 72 hours and 168 hours.
c. Number of attempts to insert VAD (including CVC). |
12 Weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
a. VIP phlebitis score at 24 hours, 48 hours, 72 hours and 168 hours. |
12 Weeks |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
11/07/2022 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
IV access is an important component of patient care, especially for
those who require long-term IV treatment like chemotherapy and supportive care.
Many studies done in other parts of the world have documented the importance of
IV access for cancer care as part of routine practices. For pediatric patients,
IV access is challenging because of their small caliber veins, anatomical variations, along with the child’s
anxiety, and withdrawal add to the difficulty of vascular access. Children
undergoing cancer treatment require IV access multiple times during their
treatment. Trained personnel for IV access for pediatric cancer patients may
reduce the chances of multiple attempts, thus less pain and shorter duration
for vein puncher. There are many devices available for vein access including
the ultrasound (US) guidance device for intravenous (IV) access. This has now
emerged as routine practice in many settings for central line placement and difficult
peripheral IV access. This is an under-researched area in developing countries
like India and the data for current practices lacks for most of the developing
countries. This study aims to explore the current practices in two cancer
centers in New Delhi that provide treatment for pediatric cancer patients. Based
upon the findings from the baseline study, a center-specific intervention for
each participating center will be done. As an intervention, a Central Venous
Catheter bundle (CVC Bundle) comprising of equipment, staff, training, SoPs, and an Ultrasound (USG) locator shall be used at the participating
center. The intervention CVC package will be developed building on the services
available currently at the participating centre with support from Cankids. The impact
of the intervention will be assessed by carrying out a post-intervention assessment
of phlebitis and quality of life in the participating centers. |