| CTRI Number |
CTRI/2024/07/071750 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find a reliable radiological landmark for accurately locating the central venous catheter position. |
|
Scientific Title of Study
|
Finding a Reliable Radiological Landmark for Accurate Central Venous Catheter Positioning. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kripa Sarah Roy |
| Designation |
Junior Resident |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Amala Institute of Medical Sciences, Amalanagar, Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9497219424 |
| Fax |
|
| Email |
kripasarah97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joe John Chirayath |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Amala Institute of Medical Sciences, Amalanagar, Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9526454443 |
| Fax |
|
| Email |
joechirayath@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joe John Chirayath |
| Designation |
Associate Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Amala Institute of Medical Sciences, Amalanagar, Thrissur
KERALA
680555
India |
| Phone |
9526454443 |
| Fax |
|
| Email |
joechirayath@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences Amala Hospital Rd, Amalanagar, Thrissur, Kerala 680555, India |
|
|
Primary Sponsor
|
| Name |
Dr Kripa Sarah Roy |
| Address |
Department of Anaesthesiology, Amala Institute of Medical Sciences, Amalanagar, Thrissur, Kerala 680555, India |
| 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 Kripa Sarah Roy |
Amala Institute of Medical Sciences |
Department of Anaesthesiology, Chavara Block, Amalanagar P.O Thrissur-680555, Kerala India
Thrissur
KERALA |
9497219424
kripasarah97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AMALA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals aging more than or equal to 18 who gets a CT chest in our institution. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aging more than or equal to 18 years and above who get a CT Chest done in our
Institution. |
|
| ExclusionCriteria |
| Details |
1. Insufficient images that hinders in identifying anatomical landmarks.
2. Adults with intrathoracic abnormalities having altered anatomical landmarks
3. Adults who have underwent thoracic surgeries. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the location of cavo-atrial junction in relation to anterior and posterior ribs.
2. To determine the location of cavo-atrial junction in relation to the upper half or lower half
of a particular thoracic vertebrae. |
1.5 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3. To determine the location of cavo-atrial junction in relation to right main bronchus.
4. To determine the location of cavo-atrial junction in relation to carina. |
1.5 Years |
|
|
Target Sample Size
|
Total Sample Size="541"
Sample Size from India="541"
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)
|
01/09/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) - As reference for future studies
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-06-2024 and end date provided 15-06-2044?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study will be conducted in our institution after getting approval from the institutional research and ethical committee. It is a cross-sectional study. All patients 18 years and above who are undergoing CT chest and meeting the inclusion criteria will be taken up for the study. The patient’s age and sex will be recorded. The following objectives will be evaluated on the CT:
1. To determine the location of the cavo-atrial junction in relation to anterior and posterior ribs. 2. To determine the location of the cavo-atrial junction in relation to the upper half or lower half of a particular thoracic vertebrae. 3. To determine the location of the cavo-atrial junction in relation to right main bronchus.
4. To determine the location of the cavo-atrial junction in relation to carina.
With the use of multiplanar, coronal view, axial cuts, and scout images, relevant mediastinal structures would be marked, such as the ribs both anterior and posterior corresponding to the Cavo-atrial junction, and corresponding vertebral levels would be noted, specifically if it corresponds to the upper or lower vertebrae. It would be indicated in the proforma. |