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CTRI Number  CTRI/2024/06/068491 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Determining the optimal length of insertion of central line using surface landmarks.  
Scientific Title of Study   Optimal length of insertion of right subclavian venous catheter inserted via supraclavicular approach - 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 Avirneni Vaishnavi 
Designation  Resident 
Affiliation  Dr. D Y Patil Medical College Hospital and Research center 
Address  Department of Anaesthesiology, Dr. D Y Patil Medical College Hospital and Research Center, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9908223940  
Fax    
Email  vaishnavi.jun12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vipul K Sharma 
Designation  Cardiac Anaesthesia Faculty 
Affiliation  Dr. D Y Patil Medical College Hospital and Research center 
Address  Department of Anaesthesiology, Dr. D Y Patil Medical College Hospital and Research Center, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7251888789  
Fax    
Email  vipulsharmacta@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vipul K Sharma 
Designation  Cardiac Anaesthesia Faculty 
Affiliation  Dr. D Y Patil Medical College Hospital and Research center 
Address  Department of anaesthesiology, Dr. D Y Patil Medical College Hospital and Research Center, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7251888789  
Fax    
Email  vipulsharmacta@hotmail.com  
 
Source of Monetary or Material Support  
Central Pharmacy, Hitech OT 5th floor, DR D.Y. Patil Medical College Hospital and Recearch Centre, Pimpri 
 
Primary Sponsor  
Name  Dr Avirneni Vaishnavi 
Address  DR D.Y. Patil Medical College Hospital And Research Centre, Pimpri 
Type of Sponsor  Private 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 Avirneni Vaishnavi  Dr. D.Y. Patil Medical College, Hospital and Research Centre  Department of Anaesthesiology, Dr. D.Y. Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA 		 9908223940

vaishnavi.jun12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Sub Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (3) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients age above 18 years of ASA II or ASA III undergoing major surgery with the need of central venous catheterisation.
 
 
ExclusionCriteria 
Details  Patient refusal
Change in mediastinal structure due to previous thoracic surgery or lung/ mediastinal neoplasm
Pregnancy
Infection at puncture site
Deranged coagulation profile
Cervical spine trauma
Patients with oesophageal varices 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proper positioning of subclavian venous line   Immediate postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of complications
 		 until removal of central line 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   16/06/2024 
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)
Modification(s)  		 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)?  

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 -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vaishnavi.jun12@gmail.com].

  6. For how long will this data be available start date provided 28-05-2024 and end date provided 01-08-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   It is a prospective observational study to determine the optimal length of insertion of Supraclavicular subclavian central line using surface landmark technique, confirmed by Trans-esophageal echocardiography and postoperative Chest Xray.
Complications like Haemothorax, Pneumothorax, Hematoma, Cardiac Tamponade will be evaluated.
 
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