CTRI Number |
CTRI/2022/04/042244 [Registered on: 28/04/2022] Trial Registered Prospectively |
Last Modified On: |
24/01/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device Surgical/Anesthesia Process of Care Changes |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A study to compare success and complication rate of inserting catheter in the large central vein (Subclavian) using either ultrasound or landmark guided approach in patient receiving mechanical ventilation. |
Scientific Title of Study
|
Comparison of success and complication rate during Subclavian vein cannulation using ultrasound guided long-axis in-plane technique and anatomical landmark guided technique in mechanically ventilated patients: A Prospective Randomized Open Label Study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sadik Mohammed |
Designation |
Associate professor |
Affiliation |
All India Institute of Medical sciences, Jodhpur |
Address |
3rd floor, OPD block, AIIMS hospital, Basani phase 2, Jodhpur, Rajasthan.
Jodhpur RAJASTHAN 342005 India |
Phone |
9414849733 |
Fax |
0291-2740741 |
Email |
drmsadik@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sadik Mohammed |
Designation |
Associate professor |
Affiliation |
All India Institute of Medical sciences, Jodhpur |
Address |
3rd floor, OPD block, AIIMS hospital, Basani phase 2, Jodhpur, Rajasthan.
Jodhpur RAJASTHAN 342005 India |
Phone |
9414849733 |
Fax |
0291-2740741 |
Email |
drmsadik@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Praveen BK |
Designation |
PG Student |
Affiliation |
ALL India Institute of Medical Sciences |
Address |
3rd floor, OPD block, AIIMS hospital, Basani phase 2, Jodhpur, Rajasthan.
Jodhpur RAJASTHAN 342005 India |
Phone |
7022642652 |
Fax |
|
Email |
praveenbk93@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical sciences, Basani phase 2, Jodhpur, Rajasthan, 342005 |
|
Primary Sponsor
|
Name |
All India Institute of Medical sciences |
Address |
Basani phase 2, Jodhpur, Rajasthan. 342005 |
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 |
Praveen BK |
All India Institute of Medical sciences |
Department of Anesthesiology and critical care, 3rd floor, OPD block, AIIMS hospital, Basani phase 2, Jodhpur, Rajasthan. 342005 Jodhpur RAJASTHAN |
7022642652 0291-2740741 praveenbk93@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
AIIMS, JODHPUR, Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Anatomical landmark guided SCV cannulation |
Placement of SCV catheter guided by anatomical landmark perioperatively or during ICU stay. |
Intervention |
Real time Ultrasound guided SCV cannulation |
Placement of SCV catheter guided by ultrasound perioperatively or during ICU stay. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
95.00 Year(s) |
Gender |
Both |
Details |
1) Patient aged 18years old or older.
2) Belonging to American Society of Anesthesiologist Physical Status 1-3.
3) Belonging to either sex.
4) Either scheduled for elective surgery requiring CVC or admitted in the ICU and receiving mechanical ventilation. |
|
ExclusionCriteria |
Details |
1) Patient having infection at the access site.
2) Patients with coagulopathy or on anticoagulation therapy.
3) Subclavian vein could not be visualised or appear thrombosed during initial screening. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To compare the first attempt success rate of SCV cannulation using the two techniques |
During Procedure |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the overall success rate of SCV cannulation using the two technique
To compare the time required for successful SCV cannulation using the two technique
To compare the complications of SCV cannulation using the two technique |
Periprocedural |
|
Target Sample Size
|
Total Sample Size="214" Sample Size from India="214"
Final Enrollment numbers achieved (Total)= "234"
Final Enrollment numbers achieved (India)="234" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/05/2022 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
31/10/2023 |
Estimated Duration of Trial
|
Years="0" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Not yet |
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 - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - On personal request by mail to drmsadik@gmail.com
- For how long will this data be available start date provided 01-01-2024 and end date provided 31-12-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
A central venous catheter (CVC) is an indwelling vascular catheter with a tip that lies within the proximal third of the superior vena cava, the right atrium, or the inferior vena cava. Central venous catheterisation was first performed in 1929 by Werner Frossman using a ureteric catheter inserted through the antecubital vein and advanced into the right ventricle under fluoroscopy. Later on Sven-Ivar Seldinger in 1953, introduced a technique that facilitates catheter placement into lumens and body cavities. Since then, placement of a CVC using the Seldinger technique revolutionized medicine by allowing safe and reliable venous access. Recently, the use of ultrasound (US) guidance and improvements in catheter care have further reduced complication rates. The CVC can be inserted through a peripheral vein or a proximal central vein, most commonly the internal jugular vein (IJV), subclavian vein (SCV), or femoral vein. Among the patients admitted in intensive care unit (ICU), the SCV is a common site of CVC placement because of several associated advantages, including a lower incidence of thrombosis and catheter related blood stream infection (CRBSI), with better patient comfort and easier nursing care. It is analternative to IJV in hypovolemic or obese patients. SCV cannulation has the advantage of fixed landmarks but may be associated with potentially severe complications, e.g.,pneumothorax or hemothorax, likely related to limited operator experience. The “global use of ultrasound†is a newer concept that highlights the role of US for central venous access not only for planning but also for identifying early and late complications. Based upon the available literature, the multidisciplinary consensus guidelines from various societies recommended the use of real-time US guidance for IJV cannulation however, the literature is insufficient to recommend the use of US during SCV cannulation. A few randomized controlled and observational studies are conducted to assess the role of real time US guidance during SCV cannulation. Hence, we are planning a randomized controlled open label study to evaluate the role of real time US guidance for SCV cannulation. We hypothesize that the use of real time US guidance during SCV cannulation would provide higher success rate and lower complication rate as compared to anatomical landmark guided technique in mechanically ventilated critically ill patients |