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临床试验/CTRI/2024/05/066970
CTRI/2024/05/066970尚未招募不适用

Accidental Catheter removal in Critically ill patients: A Prospective Observational Study

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年5月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,500
试验地点
1
主要终点
Incidence of ACR per 100 catheters & 100 catheter days will be measured

研究概览

简要总结

Catheters are necessary for medicine delivery, hydration management, monitoring, and nourishment in critically sick patients. However, accidental catheter removal (ACR) has gotten less attention because to the sudden and severe side effects, which include disturbances in medicine delivery, hydration management, and patient stability. ACR might cause life-threatening conditions during removal and reinsertion, which increases healthcare expenditures. Complications may develop depending on the catheter location, including interruptions in medication supply, renal replacement treatment, persistent bleeding, lack of oxygen supply, heart related side effects, escape of fluides in wind pipe and lungs, and death.

Factors contributing to ACR include patient organic confusion, secure device techniques, and the unit’s general safety culture. ACR measurement and prevention are critical for decreasing it. The current study aims to determine the incidence of ACR for all catheter types used in Tata Memorial Hospital’s intensive care unit and develop targeted interventions to reduce ACR, such as staff education on securement techniques, regular catheter assessments, the use of appropriate catheter securement devices, and monitoring compliance with best practices.

 We are conducting this prospective observational audit in all patients admitted in ICU to check the rate of occurance of accidental catheter removal, their causes and the side effects occuring due to it. The study will be conducted at two ICUs (FICU & SICU) at Tata memorial hospital Mumbai.

We will try to find out the rate of occurance of accidental catherer removel per 100 catheter inserted and per 100 catheter days, factor that led to catherer removal and complications associated with them.

In this study, we will enroll all patients admitted in the ICU in a period of six month. Start date of the study enrollment will be immedialy after obtaining the IEC approval and CTRI registration. Based on recent ICU admission data, a total of 1500 admissions are expected in the ICU over a 6-month period. All patietns admitted to the ICU durring the study period who have an indewelling catheter will be enrolled in the study. As patients admitted in ICU are seriosly ill and under deep sedation consent will be obtained from the patient’s relative or legally acceptable representative before starting the data collection.

研究设计

研究类型
Observational

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 admitted to the ICU during the study period who have an indwelling catheter.

排除标准

  • Those patients who do not have indwelling catheters.

结局指标

主要结局

Incidence of ACR per 100 catheters & 100 catheter days will be measured

时间窗: 6 months

次要结局

  • Factors that led to accidental Catheter Removal(6 months)
  • Consequences of Accidental Catheter removal(6 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sheila Nainan Myatra

Tata Memorial Hospital

研究点 (1)

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