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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: R579||Shock, unspecified, |
|
Intervention / Comparator Agent
|
|
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-downâ€) 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 |