Near-Infrared Light Devices Versus Landmark Approach for Peripheral Venous Access in Intensive Care Unit: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 4
- 主要终点
- Success rate on the first attempt of PIVC in ICU using NILD
研究概览
简要总结
The central venous catheter (CVC) is commonly used in intensive care unit (ICU). The primary complications associated with CVCs especially with prolonged use include thrombosis and infections. Hence, it is essential to remove the CVC as soon as it becomes unnecessary.
Peripheral intravenous cannulation (PIVC) on a critically ill patient can be a significant challenge for nurses. After several days in ICU, patients may develop significant edema in the upper limbs, complicating the PIVC.
Near-infrared light devices (NILD) are medical devices that use near-infrared light to highlight the patient's peripheral venous network directly on their skin. The advantage of this device is its minimal training and ease of use for effective application. Nurses can use this medical device without specific conditions once they have received training on its use. The vein illuminator has not been extensively studied in ICU.
This study aims to compare two techniques for PIVC in critically ill patients with existing CVC for whom maintaining the deep venous access is no longer indicated.
The investigators hypothesize that the use of the NILD would increase the success rate of first-attempt PIVC insertion compared to a landmark approach (traditional method) for PIVC in ICU.
详细描述
This is a multicenter randomized controlled study. 380 patients will be randomly assigned with a 1:1 ratio to landmark approach (standard group) or near-infrared light device (interventional group).
Randomization will be done immediately after the enrollment of the patient. Randomization will be stratified by center and according to anticipated difficult venous access defined by:
- BMI > 30 Kg/m2
- Increase in body weight between admission and day of inclusion > 10%.
- Clinically evident edema of the upper limbs (with pitting)
- Absence of visible or palpable veins on arms and forearms If one or more items are present, the patient is classified as difficult to venous access.
Once the patient has been enrolled and randomized, the nurse in charge of the patient performs the PIVC according to the randomization group as soon as possible after randomization.
The nurse will have a maximum of 3 attempts before handing over to another nurse. The total number of attempts will be 5 with the allocated method (traditional method or NILD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years old
- •Hospitalized in ICU
- •with a deep venous catheter (jugular, subclavian or femoral)
- •In whom the use of a deep venous line is no longer justified (absence of: vasopressor amines, chemotherapy, parenteral nutrition, hypertonic solutions)
排除标准
- •Absolute contraindication or anatomical impossibility to perform a PIVC on the upper limbs
- •Patient already included in the study
- •Tattoo covering most of both forearms
- •Adult subject to a legal protection measure (guardianship, curators, person under court protection)
- •Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.
- •Pregnant or breast-feeding woman
研究组 & 干预措施
near-infrared light device
the device used is the AccuVein AV500® (Accuvein, New York USA). Nurses will have to find the vein for the PIVC using the near-infrared light device. Nurses will have to proceed as follows: apply the tourniquet, put on the near infrared light onto the upper limb. PIVC on the lower limbs is forbidden in this study. The recommended projection distance is around 20 cm, however, the optimal distance of projection can vary between 10 and 45 cm. After finding the vein, Nurses proceed to PIVC with the device turned on, the peripheral venous network visible on the skin of the patient. After the cannulation and to confirm the functionality of the peripheral intravenous access a flash of 10cc of an isotonic solution (NaCl 0.9%) will be injected
干预措施: near-infrared light device (Device)
landmark approach
PIVC will be done by a nurse on an upper limb according to the standard approach. The nurse will proceed as follows: apply the tourniquet and find a vein for the catheterization, standard techniques to highlight veins can be used (apply alcohol, tap veins …). After finding a vein, the nurses proceed to the PIVC according to his / her habits. The use of any device is forbidden. After the cannulation and to confirm the functionality of the peripheral venous access a flash of 10cc of an isotonic solution (NaCl 0.9%) will be injected.
结局指标
主要结局
Success rate on the first attempt of PIVC in ICU using NILD
时间窗: Baseline
To show that the use of the NILD improves the success rate on the first attempt of PIVC in ICU for patients for whom the use of a deep venous catheter is no longer justified. The success of PIVC will be determined by the presence of venous return during catheterization in the reflux chamber, the full catheter introduction, and the administration of a 10cc syringe of isotonic solution (NaCl 0.9%) with a flash without extravasation. A puncture attempt is defined by the effraction of the skin barrier by the device. During a puncture, repositioning/change of catheter direction is permitted. Peripheral intravenous puncture will be performed by nurses only.
次要结局
- number of attempts before successful PIVC(Baseline)
- occurrence of local complications(Day 7)
- success rate of PIVC according to nurses's experience(Baseline)
- success rate of PIVC in patients considered with anticipated difficult intravenous access(Baseline)
- PIVC insertion time(Baseline)
- pain levels(Baseline)