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临床试验/CTRI/2024/10/074562
CTRI/2024/10/074562尚未招募不适用

Efficacy of long peripheral catheter (LPC) versus peripheral intravenous cannula (PIVC) for perioperative vascular access in high risk surgical patients - a randomised comparative trial

Mahatma Gandhi Medical College and Research Institute , Pondicherry1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年10月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
To measure and compare the incidence of primary device failure for 1000 catheter days

研究概览

简要总结

Venous access devices are an indispensable part of hospital care for surgical patients. Common indications for venous access devices are intravenous fluids, antibiotics, analgesics and supportive therapy. The duration of requirement of venous access device depends commonly on severity of patient’s illness, care plan, place of care and availability of alternate venous access sites. The surgical cohort has unique venous access requirements namely rapid fluid replacement during anesthesia, blood transfusions, short term peripheral administration of vasopressors in the operating room, antibiotic therapy for more than 7 days and prolonged intravenous fluid administration in patients undergoing laparotomies.

Peripheral intravenous cannula is the most frequently employed devices during patient admission but are associated with a failure rate of 40- 60 %.The common indications for PIVC removal are thrombophlebitis and catheter occlusion. Patients suffer from repeated pricks, interruption of therapy and dissatisfaction during hospital stay due to multiple PIVC insertions. The recommended dwell time for PIVC is 72 - 96 hours and thus are not right devices in patients requiring venous access more than 5 days. Long peripheral catheters are similar in design to peripheral intravenous cannula but are longer in length 8 - 10 cm and are inserted in veins above cubital fossa. They end distal to the axilla and have a median dwell time of 14 days. Ultrasound guided insertion success rates are 86 - 100 % for these catheters and have a failure rate of 14 % when compared with 42 % for PIVC.  LPCs have been studied in post cardiac surgery units and have been found to have longer dwell time and lower failure rate than PIVCs but such data regarding general perioperative cohort is lacking. Hence, we designed this trial to compare the efficacy of PIVC and LPC in surgical patients requiring venous access for 7 - 15 days in terms of device failure, average dwell time, costs of VAD, and complications such as phlebitis, occlusion and dislodgement.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Patients above 18 years of age with need for vascular access for more than one week for perioperative indications.

排除标准

  • Patients with difficult venous access , emergency surgeries , immediate requirement of central venous catheter , CKD patients , pregnant patients.

结局指标

主要结局

To measure and compare the incidence of primary device failure for 1000 catheter days

时间窗: catheter patency will be assessed every twenty four hours until device removal

次要结局

  • To measure and compare the incidence of complications for 1000 catheter days- phlebitis/ infiltration/ leak/ and thrombosis.(Catheter will be assessed every twenty four hours for complications until device removal)
  • To measure and compare the median catheter dwell time (Days)(Day of device removal)
  • To identify the number of devices utilised per patient (Ratio)(At the time of patient discharge)
  • To calculate the cost incurred by the patient for the VAD.(At the time of patient discharge)
  • To measure the patient satisfaction regarding overall performance and comfort of the VAD.(At the time of patient discharge)

研究者

发起方
Mahatma Gandhi Medical College and Research Institute , Pondicherry
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Siddharth Chandanamuthu

Mahatma Gandhi Medical College and Research Institute

研究点 (1)

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