| CTRI Number |
CTRI/2024/05/067327 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Incidence of catheter colonization in Regional Anaesthesia. |
|
Scientific Title of Study
|
A Prospective observational study of incidence of catheter colonization in regional Anaesthesia (epidural/peripheral nerve block catheter) in patients undergoing elective surgeries in CMC Vellore. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DIVYA A J |
| Designation |
JR Anaesthesia |
| Affiliation |
Christian Medical College ,Vellore |
| Address |
Junior resident,
department of Anaesthesia
Room no 909,
LIQ, Christian Medical College,
Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
8754289020 |
| Fax |
|
| Email |
jdivyaalbert@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sajan p George |
| Designation |
Professor |
| Affiliation |
Christian Medical College ,Vellore |
| Address |
Professor
Department of Anaesthesia, Christian Medical College,
Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
8098118456 |
| Fax |
|
| Email |
sajanpg@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DIVYA A J |
| Designation |
JR Anaesthesia |
| Affiliation |
Christian Medical College ,Vellore |
| Address |
Junior Resident,
department of Anaesthesia,
Room no 909,
LIQ, Christian Medical College,
Vellore.
Vellore
TAMIL NADU
632004
India |
| Phone |
8754289020 |
| Fax |
|
| Email |
jdivyaalbert@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid research Grant,
Christian medical college,Vellore,
Tamilnadu,India
pin code:632002 |
|
|
Primary Sponsor
|
| Name |
Fluid research Grant Christian Medical College Vellore |
| Address |
Christian Medical College,
Vellore district, Tamilnadu state,
India.
pin code :632002 |
| Type of Sponsor |
Private medical college |
|
|
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 Divya A J |
Christian Medical College |
Department of Anaesthesia,Christian Medical College,
Vellore.
Vellore
TAMIL NADU |
8754289020
jdivyaalbert@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board,office if research, Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgeries requiring epidural/nerve block catheters |
|
| ExclusionCriteria |
| Details |
Patient refusal, labor epidural, Paediatric age groups, Emergency surgeries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the incidence of catheter colonization in people undergoing elective surgeries |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for the associated risk factors with catheter colonization |
1 year |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
01/06/2024 |
| 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="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
|
1. An
observational cross-sectional study will be conducted during the period of
2023-2024 involving a sample size of 174. consent will be obtained from each
patient. Catheter insertion will be carried
out with a standardized aseptic technique (skin will be disinfected with
chlorhexidine; bacterial filters will be attached to catheter in sterile manner).
Temperature and local signs such as redness, swelling, tenderness will be
evaluated as long as catheter
insitu. To prevent bacterial
contamination of catheter tips, skin will be disinfected with chlorhexidine and
only after skin has dried catheter will be removed to avoid direct
contact of tip with chlorhexidine. The distal catheter tip will be cut with
sterile scissors, placed in a sterile transportation tube and transferred
immediately to microbiology laboratory.The presence of more than 15 CFC of single organism/catheter will be considered
as colonization . If accompanied by signs of local inflammation
(redness/swelling/tenderness) it will be defined as local infection. |