| CTRI Number |
CTRI/2025/07/090440 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on how neck vein-to-artery ratio impacts first-attempt success of central line insertion in surgical patients under anaesthesia”
|
|
Scientific Title of Study
|
Association between the internal jugular vein/common carotid artery ratio and the first-attempt success rate of
landmark-guided right internal jugular vein cannulation in patients undergoing elective surgeries under general
anesthesia – a prospective observational study |
| 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 Konda Tharun Reddy |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
1st floor
Department of Anaesthesiology
AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
7995169877 |
| Fax |
|
| Email |
ktharunreddy1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Molli Kiran |
| Designation |
Associate professor, Department of Anaesthesiology, AIIMS Mangalagiri |
| Affiliation |
|
| Address |
1st floor
Department of Anaesthesiology
AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
9441497323 |
| Fax |
|
| Email |
mvr934@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Konda Tharun Reddy |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Mangalagiri |
| Address |
1st floor
Department of Anaesthesiology
AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
7995169877 |
| Fax |
|
| Email |
ktharunreddy1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology AIIMS Mangalagiri GunturAndhrapradesh PIN code India |
| Address |
1st floor
Department of Anaesthesiology
AIIMS Mangalagiri
Mangalagiri
Guntur district
PIN code 522503
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Konda tharun reddy |
AIIMS Mangalagiri |
1st floor
Department of Anaesthesiology
AIIMS Mangalgiri Guntur ANDHRA PRADESH |
7995169877
ktharunreddy1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE (ECR/1416/Inst/AP/2020) All India Institute of Medical Sciences Mangalagiri, Andhra Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z452||Encounter for adjustment and management of vascular access device, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex,
18-65 years of age,
undergoing elective surgery under general anesthesia,
requiring the right internal jugular vein central venous canulation |
|
| ExclusionCriteria |
| Details |
prior neck surgeries,
anterior neck masses,
pregnant women,
patients with psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the right IJV/CCA ratio in patients with and without first-attempt success rate. |
At the time of cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To correlate the right IJV/CCA ratio with CVP
2. To assess the incidence of complications like carotid puncture, hematoma at the site of cannulation, pneumothorax, etc.
3. To estimate the normal IJV/CCA ratio in patients with & without heart disease |
After cannuation |
|
|
Target Sample Size
|
Total Sample Size="126" Sample Size from India="126"
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)
|
04/08/2025 |
| 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) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
According to prior studies, the internal jugular vein/common carotid artery (IJV/CCA) ratio can be correlated to the central venous pressure.1,2 In resource-limited settings, central venous cannulations (CVC) are carried out by anatomical landmark-guided techniques. Because of their accessibility and generally low likelihood of complications, the jugular veins are among the most often used locations for central venous access. The right IJV is the most commonly used vein for central venous catheterization due to its larger size, and runs more superficially when compared to the left IJV. Common carotid artery puncture is the most feared complication while performing IJV cannulation. A higher IJV/CCA ratio indicates that the size of the IJV is larger when compared to the CCA. The relationship between the IJV/CCA ratio and the first attempt success of landmark-guided IJV has not been studied. We hypothesize that a higher IJV/CCA ratio results in higher success of cannulating the IJV with fewer complications like CCA puncture. |