A Warning Red Flag Classification System to Predict Risk of Vasovagal Event During Office Hysteroscopy

Condition(s) studied

Investigational drug(s) / intervention(s)

Office hysteroscopy: In office hysteroscopy will utilize 1.9-2.9 mm hysteroscopes (primarily Bettocchi) by the technique of vaginoscopy, without anesthesia or up to level 3a analgesia, in accordance with International Consensus Statement for Recommended Terminology Describing Hysteroscopic Procedures. The choice of distension medium and hysteroscope is left to the operator's discretion. A nurse positioned at the head of the patient will record signs and symptoms of VVR/VVS.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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. — 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.

Trial sites (1)