National, Cross-sectional, Multicenter Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil: a Quality Improvement Study (PIVS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 3
- 主要终点
- Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications)
研究概览
简要总结
A multi-center, national prevalence study where: (1) baseline SPIVC therapy complications of hospitalized adult patients that meet the inclusion/exclusion criteria of the study and (2) the compliance of clinicians to the Hospital's evidence based practice will be measured in Brazil.
详细描述
At each participating research site, select nurse clinicians who are experienced or experts in short peripheral I.V. catheter (SPIVC) therapy, will audit medical records and observe the SPIVC sites of adult patients in various hospital wards until a minimum total of 300 SPIVC sites are audited among 3 Brazilian acute care hospitals. The wards audited will be selected by the Investigator and will be audited during a specified time period until at least 100 SPIVCs are audited. The time to complete the study will depend on the size of the select wards, the number of nurse auditors and the number of monitoring visits required.
There are no treatments. The short peripheral I.V. catheter-related medical devices (products) observed during the study are currently approved by Brazil regulatory agencies, purchased by the hospital and available to the clinician at the time of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Male or female subject, aged 18 years or older at the time of the study's audit of the ward;
- •Subject admitted into one of the wards audited at the study site;
- •Subject available for observation at the time of the audit;
- •Subject with at least one inserted PIVC;
- •Subject that voluntarily signed and dated the informed consent form (ICF) prior to study entry, if required by the study site's Ethics Committee.
排除标准
- •Subject under treatment at the study site's outpatient clinics;
- •Subject admitted into a mental health ward, emergency ward or burn unit;
- •Subject awaiting transfer to another facility.
结局指标
主要结局
Percentage of PIVCs Sites With at Least One Clinical or Mechanical Complication (PIVC-related Complications)
时间窗: From PIVC insertion to the audit, up to 7 days.
Clinical complications are: phlebitis (grade 1-4), Hematoma, Ecchymosis, Skin injury, Local infection. Mechanical complications are: Catheter dislodgement, Occlusion, Extravasation, Infiltration (grade 1-4), Leaking at the insertion site. Prevalence (%) = (Number of audited PIVC sites with at least one clinical or mechanical complication ÷ Number of audited PIVC sites) x 100
次要结局
- Percentage of PIVC Sites With at Least One Clinical and One Mechanical Complication (PIVC-related Clinical and Mechanical Complications).(From PIVC insertion to the audit, up to 7 days.)
- Percentage of PIVC Sites With at Least One Clinical Complication(From PIVC insertion to the audit, up to 7 days.)
- Percentage of PIVC Sites With at Least One Mechanical Complication(From PIVC insertion to the audit, up to 7 days.)
- Percentage of PIVC Sites With at Least One Related Quality Issue(From PIVC insertion to the audit, up to 7 days.)