A Pilot Study of a Novel Medical Device for Pharmacological Therapy: The SecHold Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- To reduce complications associated with accidental catheter withdrawals.
研究概览
简要总结
Background: Different co-creation methods were used to design and prototype a new fixative device for multiple intravenous therapies with the ability to control and identify the pharmacological therapy administered to a patient. Objectives: To validate a newly created device for the reduction of complications related to the use of intravenous therapy Methods: A multidisciplinary team composed of eight professionals specializing in the field of critical care and an engineering professional in industrial design was responsible for collecting, evaluating, and materializing the ideas and needs arising from clinical practice in a device that met the standards of the same.
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
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted to the intensive care unit
- •patients with authorization to take part in the study
排除标准
- •Patients with pre-existing medical conditions: Patients with diseases affecting coagulation, such as hemophilia or thrombocytopathies, could be excluded.
- •Active infection patients: Any patient with vascular access site infections or systemic infections may be excluded to avoid complications.
- •Inability to give informed consent: Patients who are unable to understand or consent to participate in the study.
研究组 & 干预措施
CONTROL
FIXATION OF VASCULAR ACCESSES WITH INFUSION OF THERAPY MAINTAINED IN THE TRADITIONAL WAY, DIRECTLY TO A THREE-WAY TAP AND EXTENSION FOR CONNECTION TO A CENTRAL DEVICE.
INTERVENTION
FIXATION OF VASCULAR ACCESSES WITH INFUSION OF THERAPY MAINTAINED IN THE TRADITIONAL WAY, DIRECTLY TO THREE-WAY TAP AND EXTENSION FOR CONNECTION TO CENTRAL DEVICE INCORPORATING THE SECHOLD GRIP SYSTEM FOR ATTACHMENT OF MULTIPLE DROPPERS TO IT, WITH LABELING AND ATTACHMENT TO BED/CRADLE, DROPPER STICK OR PATIENT/CARRIER CLOTHING.
干预措施: SECHOLD DEVICE (Device)
结局指标
主要结局
To reduce complications associated with accidental catheter withdrawals.
时间窗: day 1, day 7, day 14, at 6 months after placement and start of the study
Number of complications associated with accidental catheter withdrawals during the study period
To reduce the risk of complications associated with the number of pharmacological errors.
时间窗: day 1, day 7, day 14, at 6 months after placement and start of the study
Recognize the number of pharmacological errors (DRUG INTERACTION, WRONG DRUG, WRONG DOSAGE, WRONG SPEED) that have occurred
次要结局
- Reduce complications associated with venous catheter placement and maintenance (thrombosis, phlebitis, catheter obstruction).(day 1, day 7, day 14, at 6 months after placement and start of the study)