| CTRI Number |
CTRI/2025/11/097652 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
supraclavicular subclavain vein v/s IJV cannulation which is safe and better in adult pateint requiring GA. |
|
Scientific Title of Study
|
Comparative study of efficacy and safety of Ultrasound guided Supraclavicular subclavian vein cannulation versus Internal jugular vein cannulation in Adult patients posted for surgery under General anaesthesia . |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sinchana V B |
| Designation |
Junior resident |
| Affiliation |
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD |
| Address |
Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
7760847172 |
| Fax |
|
| Email |
sinchanavb1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
JYESTHARAJ VIDYASAGAR PATANGANKAR |
| Designation |
Assistant professor |
| Affiliation |
MGM MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIA MGM MEDICAL COLLEGE AND HOSPITAL N6 CIDCO AURANGABAD
MAHARASHTRA
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
880505613 |
| Fax |
|
| Email |
jyesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JYESTHARAJ VIDYASAGAR PATANGANKAR |
| Designation |
Assistant professor |
| Affiliation |
MGM MEDICAL COLLEGE |
| Address |
Department of Anaesthesia MGM Medical College and Hospital N6 CIDCO Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
880505613 |
| Fax |
|
| Email |
jyesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT complex , OT 5 and 9 ,MGM Medical College and Hospital N6 CIDCO Aurangabad ,Maharastra , India 431001
MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
MGM Medical college and Hospital Aurangabad |
| Address |
Department of Anaesthesia MGM Medical college and Hospital N6 CIDCO Aurangabad , Maharastra ,India 431001 |
| 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 |
| Sinchana V B |
MGM HOSPITAL AURANGABAD |
OT COMPLEX Aurangabad MAHARASHTRA
Aurangabad
MAHARASHTRA |
7760847172
sinchanavb1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Ethics committee For Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided Internal jugular vein cannulation |
Comparative study of efficacy and safety of Ultrasound guided Internal jugular vein in Adult patients posted for surgery under General Anaesthesia. |
| Intervention |
Ultrasound guided Supraclavicular subclavian vein cannulation |
Comparative study of efficacy and safety of Ultrasound guided Supraclavicular subclavian vein cannulatiobn in Adult patients posted for surgery under General Anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA grade I,II,III
Patients scheduled for elective or emergency surgery requiring central venous access |
|
| ExclusionCriteria |
| Details |
Patient Refusal to participate or withdrawal of consent.
Coagulopathy or thrombocytopenia .
Pregnany women
Known anatomical deformities or history of neck , clavicular or thoracic surgery affecting cannulation sites.
Local infection, burn or trauma at proposed puncture sites. |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Successful cannulation is defined as confirmed central vein cannulation(CVC) placement within the intended vein, with free aspiration of blood from all three catheter ports. A post-procedural chest radiograph will be obtained within 24 hours to assess for complications such as pneumothorax or hemothorax.
• In both the techniques mean cannulation time and number of attempts required to secure central vein catheter will be assessed
• Needle Puncture time (A): from initial vein scanning to successful vein puncture.
• Guidewire insertion time (B): from vein puncture to guidewire insertion and its confirmation via USG.• Cannulation time (C): from guidewire insertion to successful placement and confirmation of the CVC with aspiration from all three ports.
• The total central vein cannulation (CVC) time(T) will be calculated as A+B+C.
|
• Needle Puncture time (A): from initial vein scanning to successful vein puncture.
• Needle Puncture time (A): from initial vein scanning to successful vein puncture.
• Guidewire insertion time (B): from vein puncture to guidewire insertion and its confirmation via USG.
• Guidewire insertion time (B): from vein puncture to guidewire insertion and its confirmation via USG.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Needle Puncture time (A): from initial vein scanning to successful vein puncture.
• Guidewire insertion time (B): from vein puncture to guidewire insertion and its confirmation via USG.• Cannulation time (C): from guidewire insertion to successful placement and confirmation of the CVC with aspiration from all three ports.
• The total central vein cannulation (CVC) time(T) will be calculated as A+B+C.
|
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
26/12/2025 |
| 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="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
|
METHODS: After institutional ethical committee approval, the study will be registered in clinical trial registry of India (CTRI). Pre anaesthetic checkup of all patients will be done prior to general anaesthesia. Consent for participation in study will be obtained from patients. Patient or relatives will be explained about procedure. · Pre-operative parameters such as heart rate, blood pressure and oxygen saturation will be recorded. Then IV line will be secured with 20G needle & IV Fluids will be started.Generalanaesthesia will be administered using drugs as per institutional protocols and patient’s general condition, airway will be secured with endotracheal tube. · The patient will be positioned supine, with arms adducted and the neck rotated to the contralateral side. An ultrasound (USG) machine (Samsung HS 40)and 5–12 MHz linear transducer probe will be used for the procedure · Before initiating the procedure, a preliminary ultrasound scan will be conducted in all patients using gentle transducer pressure. The internal jugular vein (IJV) and supra-clavicular subclavian vein (SCV) calibers will be assessed. · With all aseptic precautions, the cannulation site is prepared and draped. · In the subclavian vein (SCV)group, Patients were placed in supine position with head turned to the left side. Subclavian vein is best found in long axis in supraclavicular fossa before it joins internal jugular vein to become right innominate vein/ brachiocephalic vein. After visualization the needle is inserted with “in plain” approach. After successful aspiration of blood,the guidewire will be advanced, and its position will be confirmed on ultrasound. Cannulation will be done using the Seldinger technique, and the catheter will be secured in supraclavicular fossa& sterile dressing will be applied.
· In the internal jugular vein (IJV) group, ultrasound (USG) transducer will be placed transversely (short-axis view) on the patient’s neck, lateral to the cricoid cartilage. The internal jugular vein (IJV) is identified as a compressible, non-pulsatile structure. After centering the right internal jugular vein (IJV) on the ultrasound screen. Using an out-of-plane technique, the vein will be punctured and after successful aspiration of blood,A guidewirewill be introduced, and its position within the internal jugular vein (IJV) will be confirmed using a short-axis USG view. A central venous catheter (CVC) will be inserted using the Seldinger technique. The catheter will be secured and sterile dressing will be applied. |