Patient Experience With Ultrasound-guided Versus Conventional Peripheral Venipuncture: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Patient's experience with the method used to obtain venous access (1/2)
研究概览
简要总结
Randomized clinical trial to compare the patient's experience after 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 of a 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: ultrasound peripheral venipuncture executed by specialized nurses (vascular access program), or
- Control: conventional peripheral venipuncture executed by clinical practice nurses..
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.
The peripheral venipuncture procedure for both groups will be performed according to the standard operating procedures recommended by the institution where the study will be conducted (HCPA). The catheters to be used will be the peripheral venous catheters made available by the institution.
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;
- •Admitted to the clinical inpatient units on 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.
结局指标
主要结局
Patient's experience with the method used to obtain venous access (1/2)
时间窗: up to 5 minutes.
Patient's experience with the method used to obtain venous access, assessed using the Net Promoter Score (NPS), a single metric instrument that quantifies the answers to a single direct research question: "How likely are you to recommend this procedure?". Three categories of respondents are identified and classified as 'promoters' (those who would definitely recommend), 'passive' (who are widely satisfied, but would not recommend) and 'detractors' (who actively discourage others from trying the procedure).
Patient's experience with the method used to obtain venous access (2/2)
时间窗: up to 10 minutes.
Additionally, it will be assessed the elements: a) patient emotional aspect during the procedure (anxiety, discomfort, importance of the procedure, fear, concern, safety); b) venous catheter insertion site; c) number of venipuncture attempts; d) dressing and device fixation on the skin; e) procedure's time duration; as relevant indicators for the characterization of the procedure as a positive or a negative experience for the patients. Data will be computed using a 10 point Likert scale score, in which 1 point rates the worst experience and 10 points an excellent experience.
Patient's experience of pain during the procedure
时间窗: up to 5 minutes.
Patient's experience of pain during the procedure of peripheral venipuncture, evaluated immediately after the procedure using the 10 cm verbal Numerical Rating Scale (vNRS). The response indicated by the patient regarding the degree of felt pain during the procedure, from 0 to 10, with 10 being the most intense pain, will be computed.
次要结局
- Peripheral intravenous catheter dwell time(Daily monitoring, until catheter removal)
- Complications during the vascular access device permanence(Daily monitoring, up 2 days after catheter removal)