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临床试验/CTRI/2022/05/042932
CTRI/2022/05/042932尚未招募不适用

Incidence of CVC related complications and risk factors associated with them in atertiary care teaching hospital in INDIA

PGIMER3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
PGIMER
入组人数
150
试验地点
3
主要终点
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

研究概览

简要总结

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 Seldinger’s technique(safer than previous “cut-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 doesn’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

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 1.Denial of consent.

结局指标

主要结局

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

时间窗: T0-Baseline- Immediately after cannulation | T6-6 hours After CXR | T12- 12 Hours after cannulation

次要结局

  • To determine the relative risk and odd ratio for the following factors associated with the complications(1.Emergent nature of procedure)

研究者

发起方
PGIMER
申办方类型
Research institution and hospital

研究点 (3)

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