Anesthesia Clinical Practice During Labour Neuraxial Analgesia: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Informed consent
研究概览
简要总结
The goal of this observational study is to evaluate the communication between the anesthesiologist and the patient prior the initiation and during the administration of the labor neuraxial analgesia.
The investigators hypothesize that there will be differences among anesthesiologists during the informed consent process and communication during the procedure, specifically, how the anesthesiologists describe the technical aspects of the procedure, alternatives, risks, complications, and expected effects of labour neuraxial analgesia.
The anesthesiologists will be observed during a routine labor neuraxial analgesia procedure for healthy uncomplicated patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all obstetric anesthesiologists working in maternity unit
排除标准
- •any comorbidity of the patient that would necessitate deviation from a routine practice for the initiation of labor neuraxial analgesia
结局指标
主要结局
Informed consent
时间窗: From the first contact with the patient before labour neuraxial analgesia until the procedure is finished.
Incidence of key elements (such as technique desciption, alternatives, risks, complications, and expected effects) during the consent process before the labour neuraxial analgesia procedure. This will be assessed using a structured observation checklist with dichotomous variables (yes/no).
次要结局
- Procedure description(During the standard clinical consent process provided to patients prior to the administration of labour neuraxial anesthesia.)
- Additional labour analgesia options(During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.)
- Risks and complications(During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.)
- Anticipated effects(During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.)
- Patient information sheets(During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.)
研究者
Vit Gunka
Site Principal Investigator
University of British Columbia