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临床试验/NCT06589661
NCT06589661招募中不适用

The Patient AS EDUcator in Anesthesia: Exploring the Patients' Experience During and After Unexpected Cesarean Delivery Under General Anesthesia to Inform Anesthetic Practice. A Prospective Patient-centred Multidisciplinary Mixed-method. (PAS-EDU-uCD-GA)

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
Patient questionnaire

研究概览

简要总结

This study aims to explore the patients' and providers' perspectives and inform future anesthetic practice for patients undergoing unexpected cesarean delivery (CD) under general anesthetic (GA). The consideration of patients' concerns, preferences, expectations, and suggestions may lead to enhanced patient satisfaction, compliance, and quality of care that future patients receive during unexpected CD under GA. The investigators will possibly be able to identify gaps in procedural performance that warrant further investigation during the second phase of this study which will contribute to improvement of overall patient care. During the third phase, educational material will be generated from patient insights and will be distributed to the Department of Anesthesia, Department of Obstetrics and Gynaecology, Labour and Delivery Nurses and team of Anesthesia Assistants and Respiratory Therapists.

详细描述

Cesarean delivery (CD) is a surgical procedure that allows for birth of a neonate through a laparotomy and hysterotomy and is the most common surgical procedure performed worldwide with 21% of all childbirths occurring via CD.

A single-shot spinal anesthesia is the most common technique for CD due to its simplicity, quality of sensory blockade and reliability, as well as because of the safety for the fetus. Nevertheless, there are clinical situation where general anesthesia is necessary. General anesthesia care in obstetric scenarios remains a serious concern because of a high failed intubation rate, accidental awareness, increasing association with postpartum depression requiring hospitalization, suicidal ideation and self-inflicted injury, and traumatic birth experiences. General anesthesia for CD might not be planned and pivoting to this unexpected type of anesthesia can be a traumatic experience for patients and their families. Patients may receive a GA for various reasons, including failed neuraxial anesthesia, hemodynamic instability, or critical fetal situations not amendable to neuraxial anesthesia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • aged 18 years or older
  • English language proficiency (as interviews will be performed in English)
  • ASA Physical Classification Score 2-5 +/- E
  • Emergency or Urgent Cesarean Delivery with the need for general anesthesia due to fetal or maternal emergencies (e.g., fetal bradycardia, HELLP syndrome, etc.)
  • Unexpected Cesarean Delivery is defined as Level 1 (Emergency - Immediate threat to life of woman or fetus) and Level 2 (Urgent - Maternal or fetal compromise which is not immediately life-threatening) Cesarean Deliveries.21
  • Patients will be included if they undergo preterm delivery (under 37 weeks of gestation, or are having a multiple gestation pregnancy, also, if there is a significant fetal anomaly present.
  • Exclusion criteria:
  • Under 18 years of age
  • Unable to answer questions due to a language barrier or because of their mental or physical state (e.g., intubated patients)
  • BMI at the time of delivery that falls in the super-morbidly obese category (BMI > 55 kg/m2)
  • Patients who underwent preterm delivery (under 32 weeks gestation)
  • Patients will be excluded if neonatal death has occurred.
  • Patients who were scheduled for an elective Cesarean Delivery, but had contraindicated or failed neuraxial anesthesia and required general anesthesia for or during their CD will be excluded.

排除标准

  • 未提供

结局指标

主要结局

Patient questionnaire

时间窗: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).

Patients will be asked to rate their experience of having a cesarean delivery under general anesthesia, in terms of satisfaction and their experience with any discomfort. Some questions are yes/no, some are on a scale from 1-10, where 1 = not at all and 10 = totally agree, and some are open-ended. The questionnaire will take approximately 10 minutes to complete.

Patient interview

时间窗: Following cesarean delivery, and prior to hospital discharge (at approximately 48 hours postpartum).

Patients will be interviewed in person by a member of the research team and asked open ended questions. Interviews will be recorded, transcribed and coded for themes. Responses are not reported on any scale. The interview will take approximately 30 minutes to complete.

次要结局

未报告次要终点

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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