ultraSound Guided PEripheral Catheterization Increases First-atTempt Success RAte in Hospitalized Patients When Compared With Conventional Technique: SPECTRA - Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Number of venipuncture attempts
研究概览
简要总结
Randomized clinical trial to test the assertiveness on the peripheral vein puncture attempt by comparing two methods: peripheral venipuncture catheterization using the conventional technique (vein visualization and palpation) versus ultrasound-guided venous puncture.
Patients with indication of peripheral venous puncture, admitted to the clinical inpatient units on the hospital where the study will be conducted (Hospital de Clinicas de Porto Alegre - HCPA) will be enrolled in this single-center trial and will be randomized to conventional peripheral venipuncture performed by a registered nurse; or ultrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access.
详细描述
Study Protocol:
When there is a need for peripheral venous access for the inpatient, the medical or nursing care team will contact the researchers, informing the personal data of the possible candidate to participate in the study. By fulfilling the eligibility criteria, the patient will be invited and informed about the study proposal; and, if he agrees to participate, he will sign the consent form. The type of procedure to be performed will be randomized through a draw. The procedure options are:
Intervention: peripheral venipuncture guided by ultrasound by a registered nurse with expertise in vascular access, or Control: conventional peripheral venipuncture by an inpatient care registered nurse.
Individuals who do not agree to participate in the study will have their data stored on a patient exclusion checklist.
In both groups, intervention and control, up to two attempts will be made by the same professional and, if there is no success on the procedure, another professional will be designated for two more attempts. Ultrasound Site Rite 8 or Ultrasound Site Rite 5, which are portable ultrasound devices that include 2D ultrasound imaging in real time, will be used on the Intervention Group (1) procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Researchers and investigators responsible for data collection will be blinded for collection and analysis of data.
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
- •Adults, age = or > 18 years;
- •Both sex;
- •Admitted to the clinical inpatient units of the hospital where the study will be conducted (HCPA), with indication of peripheral venous puncture;
- •Patients who do not configure emergency care.
排除标准
- •Patients who have already received ultrasound-guided peripheral venipuncture at the current hospitalization;
- •Patients in a critical or unstable clinical condition;
- •Patients admitted to surgical units at HCPA;
- •Patients in coronavirus (COVID-19) care units.
研究组 & 干预措施
Experimental: intervention group
Ultrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access.
干预措施: Ultrasound-guided peripheral venipuncture (Device)
Control group
Conventional peripheral venipuncture performed by a registered nurse.
干预措施: Conventional peripheral venipuncture (Device)
结局指标
主要结局
Number of venipuncture attempts
时间窗: Immediately after the procedure.
Success in the first attempt of venipuncture will be defined by the presence of blood reflux and infusion of 2 mL of saline without complaint of pain or signs of infiltration around the vessel. The number of times the vascular device reaches the skin and subcutaneous tissue with or without rupture of the vessel will be computed.
次要结局
- Classification of peripheral venous system conditions(Right before the procedure)
- Peripheral venous catheters characteristics(Before the procedure.)
- Vascular and device complications(Up to 8 days.)
- Venipuncture durability without complications(Up to 8 days.)
- Infusional therapy characteristics and venipuncture durability(Up to 8 days.)
- Costs related to the venipuncture techniques used(Up to 8 days.)
- Time to obtain peripheral venous access(During the procedure)