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CTRI Number  CTRI/2023/10/058552 [Registered on: 12/10/2023] Trial Registered Prospectively
Last Modified On: 11/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the safety of Ultrasound guided centre line placement in wide neck vein between above and below the collar bone approach in ICU patients. 
Scientific Title of Study   "Comparison of safety and efficacy in ultrasound guided supraclavicular and infraclavicular subclavian vein cannulation in ICU patients:A randomized clinical 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 Shailendra Kumar Patel  
Designation  Junior resident  
Affiliation  UPUMS Saifai Etawah  
Address  Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah
Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India 
Phone  6387151349  
Fax    
Email  shaim.kpatel.111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Urvashi Yadav 
Designation  Professor  
Affiliation  UPUMS Saifai Etawah  
Address  Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah Uttar Pradesh
Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah Uttar Pradesh
Etawah
UTTAR PRADESH
206130
India 
Phone  6387151349  
Fax    
Email  drurvikgmu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shailendra Kumar Patel  
Designation  Junior resident  
Affiliation  UPUMS Saifai Etawah  
Address  Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah
Department of anesthesiology Uttar Pradesh university of medical sciences Saifai Etawah Uttar Pradesh
Etawah
UTTAR PRADESH
206130
India 
Phone  6387151349  
Fax    
Email  shaim.kpatel.111@gmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh university of medical sciences Saifai Etawah  
 
Primary Sponsor  
Name  Uttar Pradesh university of medical science Saifai Etawah  
Address  Uttar Pradesh university of medical science Saifai Etawah Uttar Pradesh India PIN Code-206130 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailendra Kumar Patel   Uttar Pradesh university of medical sciences   Department of anesthesiology and critical care
Etawah
UTTAR PRADESH 		 6387151349

shaim.kpatel.111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee UPUMS Saifai   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G463||Brain stem stroke syndrome, (2) ICD-10 Condition: I631||Cerebral infarction due to embolism of precerebral arteries, (3) ICD-10 Condition: O151||Eclampsia complicating labor, (4) ICD-10 Condition: A09||Infectious gastroenteritis and colitis, unspecified, (5) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (6) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, (7) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  USG guided subclavian vien cannulation by infraclavicular approach in ICU patients   Under all aseptic precaution USG guided subclavian vein cannulation by using infraclavicular approach in ICU patients aged more than 18 years will be done. Vital monitoring devices will be attached to the patient. USG guided subclavian vein will be visualised by infraclavicular approach and CVP line will be inserted via Seldinger method. From patients preparation to central line placement in subclavian vien estimated total duration will be approximately 30 minutes. Patient will be intervene only for a single time. 
Intervention  USG guided subclavian vien cannulation by supraclavicular approach in ICU patients   Under all aseptic precaution USG guided subclavian vein cannulation by using supraclavicular approach in ICU patients aged more than 18 years will be done. Vital monitoring devices will be attached to the patient. USG guided subclavian vein will be visualised in supraclavicular approach and CVP line will be inserted via Seldinger method. From patients preparation to central line placement in subclavian vien estimated total duration will be approximately 30 minutes. Patient will be intervene only for a single time. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients of age more than 18 years of both gender requiring central line placement for therapeutic or monitoring purpose. 
 
ExclusionCriteria 
Details  1.Patient/attendant refusal
2.Patient having an infection at puncture site
3.Patient having pneumothorax/SVC syndrome
4.Patient having coagulation abnormality
5.Patient having distorted anatomy of neck or fracture clavicle,
6.Patient having platelets count less than 50000/dl. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the complications during USG guided supraclavicular and infraclavicular subclavian vein cannulation  up to 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the success rate of subclavian vein cannulation, procedure time, CVC related blood stream infection in both approaches.  up to 7 days. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/10/2023 
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 Yet Recruiting 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Nil

  6. For how long will this data be available start date provided 22-11-2023 and end date provided 22-11-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Central vein catheter (CVC) insertion is an essential and routine procedure of modern medicine in critically ill patients in intensive care unit (ICU). CVC catheterization is required for both invasive monitoring as well as therapeutic purposes. USG guided subclavian vein cannulation is associated with lesser numbers of complications as compared to blind landmark technique.The aim of study is to determine the difficulties and advantages of subclavian venous
catheterization using supraclavicular versus and infraclavicular approach under real time ultrasound guidance in ICU patients. Primary objective of this study is to compare the complications during USG guided supraclavicular and infraclavicular subclavian vein cannulation. This prospective, randomized, comparative study will be conducted after approval from the institutional ethical committee. All the patients will be assessed and check-up will done including detail history, general and systemic examination and clinical laboratory tests will be conducted. Patients or their relatives will be explained about the concerned technique and written and informed consent will be obtained.
This hospital based study will be conducted on 80 critically ill patients requiring CVC insertion. Patients who will be admitted to surgical ICU for intensive management whether mechanically ventilated or on spontaneous ventilation of age >18 years will be randomly assigned to two groups of 40 each using computer generated number table. The allocations will be concealed in sequentially numbered, sealed, opaque envelopes.
 
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