Number of complications and risk factors associated with Central line inserted in a teaching hospital in INDIA

Not yet recruiting

Conditions: Shock, unspecified,

Registration Number: CTRI/2022/05/042932

Lead Sponsor: PGIMER

Brief Summary: Centralvenous catheterization is a common procedure done in health care facilities toprovide supportive and interventional therapies to patients. The veins usuallycatheterized are internal jugular vein, subclavian vein, and femoral vein.Common indications for the requirement of central venous access are limitedperipheral venous access, administration of drugs like inotropes orvasopressors, highly osmotic or caustic drugs/fluids, volume resuscitation orblood product administration, central venous pressure monitoring amongstothers.2 Most central line are placed using Seldingerâ€™s technique(safer than previous â€œcut-downâ€) in which a central vein is cannulated using aneedle 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 ofguidewire. Cannulation is usually performed under sonographic guidance unlessthe ultrasound machine is unavailable, or the circumstances doesnâ€™t allow theuse of ultrasound. In such scenarios, landmark technique is used to cannulate avein. Despite the use of ultrasound and overall safety of this procedure,complications do occur.3

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

There are few mechanical andthrombo-embolic complications that can occur at the time of central veincauterization or in the immediate post procedure time. Thrombo-emboliccomplications like air embolism or guide wire embolism and mechanicalcomplications like arterial puncture, hemorrhage, intra-arterial placement ofcatheter, haemothorax, pneumothorax, arrhythmias, injury to thoracic duct andcardiac tamponade can occur with varying incidence and severity.4Therefore, we have planned this studyto evaluate the incidence of complications of CVC and the risk factorsassociated along with in our tertiary care centre since similar data has notpreviously been collected and evaluated.

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

Astudy conducted by Babu et al in 2018, compared the outcomes, cost and patientsatisfaction scores in patients receiving CVC vs. chemoport in situ andconcluded that CVC/PICC are more convenient as compared to the chemoport forvenous access in chemotherapy patients.5 A systematic review done by Ullman et al in 2015collected data of CVC failure and complication rate in paediatric populationbefore completion of therapy.6 Kaur et al conducted a study in intensive care unit ofteritary care hospital and concluded that bleeding complicationsoccurred more frequently with IJV insertions and infectious complicationsoccurred more commonly in cannulae that were left in situ for longer than 7days.7 Aretrospective clinical audit was done by Agarwal et al in 2012 to assess the incidenceof malposition of CVC using a landmark technique. They also found a correlationbetween the experience of the operator and the number of complicationsencountered by them.8

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

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.
Any side IJV/SCV or femoral cannulation.

Exclusion Criteria

1.Denial of consent.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To determine the relative risk and odd ratio for the following factors associated with the complications	1.Emergent nature of procedure

Trial Locations

Locations (3): Advanced Cardiac Centre,PGIMER,Chandigarh
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Chandigarh, CHANDIGARH, India
Advanced Trauma Centre,PGIMER,Chandigarh
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Chandigarh, CHANDIGARH, India
Nehru Hospital
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Chandigarh, CHANDIGARH, India
Advanced Cardiac Centre,PGIMER,Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Dr Anjuman
Principal investigator
9888443570
achander08@gmail.com