| CTRI Number |
CTRI/2024/10/074676 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of simulation training on central line insertion performance |
|
Scientific Title of Study
|
Effect of Just-In-Time simulation training on central venous catheter insertion performance: a randomized controlled 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 |
Dr Meghna Saraswat |
| Designation |
Junior resident |
| Affiliation |
AIIMS New Delhi |
| Address |
AIIMS New Delhi
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI
110049
India |
| Phone |
7017522398 |
| Fax |
|
| Email |
meghnasaraswat97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhil Kant Singh |
| Designation |
Additional professor |
| Affiliation |
AIIMS New Delhi |
| Address |
AIIMS Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi
South West
DELHI
110029
India |
| Phone |
9811702808 |
| Fax |
|
| Email |
dr.akhilsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhil Kant Singh |
| Designation |
Additional professor |
| Affiliation |
AIIMS New Delhi |
| Address |
AIIMS Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi
South West
DELHI
110029
India |
| Phone |
9811702808 |
| Fax |
|
| Email |
dr.akhilsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS New Delhi
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 india |
|
|
Primary Sponsor
|
| Name |
Dr Meghna Saraswat |
| Address |
AIIMS New Delhi
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Other [Self] |
|
|
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 Meghna Saraswat |
AIIMS New Delhi |
Anaesthesiology, pain medicine and critical care department Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South West
DELHI |
7017522398
meghnasaraswat97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, All India Institute of Medical Sciences |
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 |
| Comparator Agent |
Conventional training group |
Conventional training group will undergo mastery learning atleast 4 weeks before their first procedural skill assessment.
Mastery learning is a form of competency based education in which learners acquire essential skills and knowledge measured rigorously in relation to high and fixed achievement standards without restricting learning time to a uniform interval to reach the outcome. In mastery learning education, results are uniform, with little or no variation, whereas education time to achieve mastery may vary among trainees.
The residents in this group will be made to undergo a structured Central venous catheter insertion training program which will involve video instructions and hands on practice time with an ultrasound guided CVC insertion manikin. This training will be supervised by trainers adept in simulation based mastery learning techniques. An expert rated checklist will be used to assess the performance of the resident during training. A checklist score of more than 50 out of 54 will be the minimum passing standard. The simulation based mastery learning methodology entails proficiency at a procedure without regard to the time involved in attaining it. Training will continue till the resident is able to achieve the minimum passing standard during three consecutive simulated ultrasound guided central venous catheter insertions. This will be followed by a debriefing session which will include a review of the checklist.
Duration 45 minutes |
| Intervention |
Just in time training group |
Residents in the intervention group will undergo Just-In-Time training (JiT) for ultrasound guided central venous line insertion. The JiT session will be carried out immediately before the procedural skill assessment. The JiT session will be facilitated by a faculty member experienced in simulation teaching and will involve review of the essential steps of the procedure and the checklist.
Duration 45 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Anaesthesiology junior residents who have placed at least 10 central lines under supervision.
|
|
| ExclusionCriteria |
| Details |
Unwillingness to participate in the study by the anaesthesiology junior residents |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the difference in checklist scores over time (skill decay) while assessing CVC cannulation in residents who undergo JiT training vs those who undergo conventional simulation training.
|
Placing USG probe on skin to Flushing of last CVC port which will be done at baseline, then again at 4 weeks and lastly at 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the difference in number of cannulation attempts in residents who undergo JiT training vs those who undergo conventional simulation training.
|
Placing USG probe on skin to Flushing of last CVC port which will be done at baseline, then again at 4 weeks & lastly at 8 weeks
|
To determine the difference in total time taken for CVC cannulation in residents who undergo JiT training vs those who undergo conventional simulation training.
|
Placing USG probe on skin to Flushing of last CVC port which will be done at baseline, then again at 4 weeks & lastly at 8 weeks
|
To determine the difference in the number of procedural errors in residents who undergo JiT training vs those who undergo conventional simulation training.
|
Placing USG probe on skin to Flushing of last CVC port which will be done at baseline, then again at 4 weeks & lastly at 8 weeks
|
To determine the difference in the number of complications in residents who undergo JiT training vs those who undergo conventional simulation training.
|
Placing USG probe on skin to Flushing of last CVC port which will be done at baseline, then again at 4 weeks & lastly at 8 weeks
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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 - NO
|
|
Brief Summary
|
To assess difference in checklist scores between the conventional training group and the Just in time training group in CVC placement. A procedural assessment for all residents will be carried out. The assessment will be carried by an independent rater blinded to the type of simulation training received by the resident using the expert rated checklist. The residents will also be assessed on the number of procedural errors they commit during the procedure using a Procedural errors checklist. Procedure related data which will include no. of attempts for venous puncture, total time (from placing of USG probe on skin to flushing of last CVC port) and patient related data will be collected. Data will also be collected on self-reported resident confidence and competence on a Likert scale.
This assessment will be done a total of three times for each resident. Second and third assessments will be done at least 4 weeks after the baseline and the second assessment, respectively. Demographic data will be represented using descriptive statistics. Shapiro-Wilk test will be used for checking normality. Groups will be compared using independent samples t-test. Other tests as appropriate will be applied.
|