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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  
Safdarjung Hospital 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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