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CTRI Number  CTRI/2022/05/042932 [Registered on: 31/05/2022] Trial Registered Prospectively
Last Modified On: 30/05/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Number of complications and risk factors associated with Central line inserted in a teaching hospital in INDIA 
Scientific Title of Study   Incidence of CVC related complications and risk factors associated with them in a tertiary care teaching hospital in INDIA 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish Singh Aditya 
Designation  Assistant Professor 
Affiliation  PGIMER 
Address  Department Of Anaesthesia and Intensive Care PGIMER Sector 12 Chandigarh-160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9914406496  
Fax    
Email  ashish09399@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ashish Singh Aditya 
Designation  Assistant Professor 
Affiliation  PGIMER 
Address  Department Of Anaesthesia and Intensive Care PGIMER Sector 12 Chandigarh-160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9914406496  
Fax    
Email  ashish09399@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anjuman Chander 
Designation  Senior Resident 
Affiliation  PGIMER 
Address  Department Of Anaesthesia and Intensive Care PGIMER Sector 12 Chandigarh-160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9888443570  
Fax    
Email  achander08@gmail.com  
 
Source of Monetary or Material Support  
PGIMER, chandigarh, India 
 
Primary Sponsor  
Name  PGIMER 
Address  Department of Anaesthesia and Intensive Care, Sector-12 Chandigarh 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anjuman  Advanced Cardiac Centre,PGIMER,Chandigarh  Advanced Cardiac Centre,PGIMER, Sector-12,Chandigarh
Chandigarh
CHANDIGARH 
9888443570
0172-2756500
achander08@gmail.com 
Dr Anjuman  Advanced Trauma Centre,PGIMER,Chandigarh  Advanced Trauma Centre,PGIMER, Sector-12,Chandigarh
Chandigarh
CHANDIGARH 
9888443570
0172-2756500
achander08@gmail.com 
Dr Ashish Singh Aditya  Nehru Hospital  PGIMER, Chandigarh, India
Chandigarh
CHANDIGARH 
9914406496
0172-2756500
ashish09399@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER Instituional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R579||Shock, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients of all age group and gender
2.Central line inserted in emergency or elective setting
3.Line inserted under Ultrasound guidance or using landmark technique.
4. Any side IJV/SCV or femoral cannulation.
 
 
ExclusionCriteria 
Details  1.Denial of consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of each of the following mechanical complications (like arterial puncture, hemorrhage, intra-arterial placement of catheter, hemothorax, pneumothorax, arrhythmias, injury to thoracic duct, cardiac tamponade and air or guidewire embolism) related to central venous catheter insertion
 
T0-Baseline- Immediately after cannulation
T6-6 hours After CXR
T12- 12 Hours after cannulation


 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the relative risk and odd ratio for the following factors associated with the complications
1.Emergent nature of procedure
2.Non-optimal positioning
3.Absence of assistant
4.Presence of coagulopathy (below normal PTI/INR/Platelet count)
5.Absence of ultrasound machine 
T0- Baseline 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/06/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Central venous catheterization is a common procedure done in health care facilities to provide supportive and interventional therapies to patients. The veins usually catheterized are internal jugular vein, subclavian vein, and femoral vein. Common indications for the requirement of central venous access are limited peripheral venous access, administration of drugs like inotropes or vasopressors, highly osmotic or caustic drugs/fluids, volume resuscitation or blood product administration, central venous pressure monitoring amongst others.2 Most central line are placed using Seldinger’s technique (safer than previous “cut-down”) in which a central vein is cannulated using a needle and a guide wire is passed through the needle to maintain the tract. Later, a multi-lumen catheter is passed over the guidewire before removal of guidewire. Cannulation is usually performed under sonographic guidance unless the ultrasound machine is unavailable, or the circumstances doesn’t allow the use of ultrasound. In such scenarios, landmark technique is used to cannulate a vein. Despite the use of ultrasound and overall safety of this procedure, complications do occur.3

Complications can be divided into immediate or delayed and further into infectious, mechanical and thrombotic. As it takes time for the microbes to grow on catheter, thus immediate infectious complications are negligible.

There are few mechanical and thrombo-embolic complications that can occur at the time of central vein cauterization or in the immediate post procedure time. Thrombo-embolic complications like air embolism or guide wire embolism and mechanical complications like arterial puncture, hemorrhage, intra-arterial placement of catheter, haemothorax, pneumothorax, arrhythmias, injury to thoracic duct and cardiac tamponade can occur with varying incidence and severity.4 Therefore, we have planned this study to evaluate the incidence of complications of CVC and the risk factors associated along with in our tertiary care centre since similar data has not previously been collected and evaluated.

Although central line insertion is a common practice for gaining vascular access but associated with numerous complications. Complications related to CVC increase the morbidity and mortality of the patients leading to increased hospital stay.

A study conducted by Babu et al in 2018, compared the outcomes, cost and patient satisfaction scores in patients receiving CVC vs. chemoport in situ and concluded that CVC/PICC are more convenient as compared to the chemoport for venous access in chemotherapy patients.5 A systematic review done by Ullman et al in 2015 collected data of CVC failure and complication rate in paediatric population before completion of therapy.6 Kaur et al conducted a study in intensive care unit of teritary care hospital and concluded that bleeding complications occurred more frequently with IJV insertions and infectious complications occurred more commonly in cannulae that were left in situ for longer than 7 days.7 A retrospective clinical audit was done by Agarwal et al in 2012 to assess the incidence of malposition of CVC using a landmark technique. They also found a correlation between the experience of the operator and the number of complications encountered by them.8

 
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