Prospective Clinical Evaluation of BD Spinal Needles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).
研究概览
简要总结
Post-market, observational study to assess the real-world safety and efficacy of BD Spinal Needles used in an on-market fashion.
详细描述
Single-arm, post-market, observational, prospective study of participants who will receive neuraxial procedures with a BD Spinal Needle as part of their routine medical care.
Patients will be followed from BD Spinal needle insertion up to 7 days after the insertion according to the routine medical care and site policy.
Data collected will be gathered from the patient's medical charts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient, regardless of age or gender, for which the investigator has decided that a neuraxial procedure must be performed utilizing BD Spinal Needles as part of their routine medical care
- •Expected to be available for observation through the study period (7-days post procedure)
- •Provision of signed and dated informed consent form (Note: Consent of guardian or parent may be required for patients under the age of 18 years; participant assent may be required as well.)
排除标准
- •Undergoing emergency surgery
- •Coagulopathy or bleeding disorder for which regional anesthesia poses an increased risk
- •History of neurological impairment or disease of the trunk or lower extremities.
- •Infection at or near the site of needle insertion
- •Previous spine surgery at the level involved in the study procedure
结局指标
主要结局
Primary Safety: Incidence of Post-dural Puncture Headache (PDPH).
时间窗: From insertion up to 7 days post procedure
Percentage of participants with a diagnosis of PDPH in the 7 days following the anesthesia procedure.
Primary Performance: Incidence of Successful Needle Placement
时间窗: During the insertion procedure
Successful needle placement in the subarachnoid space defined as the appearance of cerebrospinal fluid from the spinal needle hub.
次要结局
- Secondary Safety: Incidence of Any Needle or Procedure-related Nerve Damage (Pain or Weakness Lower Extremities).(From insertion up to 7 days post procedure)
- Secondary Safety: Incidence of Any Needle or Procedure-related Pain, Skin Redness, Irritation at or Near the Skin Puncture Site.(From insertion up to 7 days post procedure)
- Secondary Safety: Incidence of Any Needle or Procedure-related Backache.(From insertion up to 7 days post procedure)
- Secondary Safety:Incidence of Any Needle or Procedure-related Spinal/Epidural Hematoma.(From insertion up to 7 days post procedure)
- Secondary Safety: Incidence of Any Needle or Procedure-related Infection (Meningitis, Spinal Abscess)(From insertion up to 7 days post procedure)