A New Red Flag Classification to Predict Vasovagal Event During Office Hysteroscopy: A Prospective Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To evaluate the feasibility of a predictive red flag classification system for identifying patients at risk of vasovagal syncope during office hysteroscopy(OH), with the goal of enhancing procedural safety.
研究概览
简要总结
The goal of this pilot cross sectional study is to identify participants at risk of vasovagal reaction/syncope(VVR/VVS) during office hysteroscopy. A predictive red flag classification system is being studied to improve procedural safety during office hysteroscopy. Researchers will perform office hysteroscopy as per the standard protocol by vaginoscopic technique. A nurse positioned at the head side of the participant will record signs and symptoms of VVR/VVS. The participant will be asked of the severity of the pain experienced during office hysteroscopy in relation to their menstrual cycle. The procedure will be discontinued at any point the participant wishes to stop.
详细描述
Office hysteroscopy is increasingly utilized due to advancements in instrumentation and techniques; however, its adoption in routine gynecologic practice remains limited to 10-12% of cases. This under utilization is largely attributed to the perception of pain and lack of financial incentives. Consequently, fewer than 20% of gynecologists employ office hysteroscopy for the evaluation of intrauterine pathology.
Although generally safe, vasovagal syncope (VVS) is the most concerning complication, with a reported prevalence ranging from 0.21% to 1.85%. Other complications include pain, infection, and bleeding. Surgeons often fail to anticipate vasovagal responses during the procedure. This study aims to develop a red flag classification system based on pain response to enable early recognition and prevention of VVS during office hysteroscopy.
Research design This is a single center, prospective observational pilot study enrolling women undergoing office hysteroscopy over 10 months.
Sample Size Calculation As this is a pilot feasibility study, a formal power calculation for hypothesis testing was not applicable. Sample size was determined using a precision-based approach. Based on a published vasovagal event rate of 6.5 % during office hysteroscopy, we estimated that 100 participants would be required to estimate this proportion with a 95% confidence interval and a margin of error of ±5%, using the Wilson score method. No formal stopping rules or interim analyses were pre-specified, consistent with the pilot and exploratory nature of this study.
Statistical Analysis Descriptive analysis will be conducted for continuous and categorical variables. Chi-square tests will evaluate the association between pain classification and vasovagal events. The STROBE checklist will guide reporting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ≥18 years
- •Prior gynecological care
- •Informed consent provided
排除标准
- •Inability to consent
- •Psychiatric disorders or anxiolytic use
- •Use of dilators or anesthesia above level 3a
- •Family history of VVS
结局指标
主要结局
To evaluate the feasibility of a predictive red flag classification system for identifying patients at risk of vasovagal syncope during office hysteroscopy(OH), with the goal of enhancing procedural safety.
时间窗: The tolerance level will be assessed perioperative/periprocedural, i.e from the initiation of OH procedure until the completion of the OH procedure.
During OH, a nurse positioned at the head of the patient will measure and record the tolerance level of the patient at the completion of the procedure using the Red flag Classification: Level Description Classification 0 Pain ≤ normal menstruation (Well tolerated) Green Flag 1. Pain \> menstruation, no signs of distress (Tolerated) Green Flag 2. Level 1 + objective signs (sweating, pallor, malaise) (Tolerated)Red Flag 3. Level 2 + facial pallor ± loss of consciousness (Not tolerated) Red Flag Normal menstruation is when the pain during periods does not interfere with daily activities. The level of pain tolerated by the women in relation to the menstruation. The feasibility will be assessed by 1) the checking the nurses records which capture the pain scores for any delays or missing data, 2 ) the number of post- procedural pain and tolerance score recorded by the nurse, 3) time taken to complete data 4)Completeness of the data. This information will be used to refine the protocol.
次要结局
- To assess the potential barriers in implementing the red flag classification system, as preparation for a future large-scale validation study(The tolerance level will be assessed perioperative/periprocedural, i.e from the initiation of OH procedure until the completion of the OH procedure.)
研究者
Tanvir Singh
Dr
Tanvir Hospital