ECO-CAM: Pre-anesthetic Consultations During Pregnancy: Benefits of Teleconsultation for Patient Assessment, Information, and Ecological Impact
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Composite quality criterion
研究概览
简要总结
Quality of teleconsultation in comparison to face-to-face consultation for pre anesthetic evaluation in pregnant persons before delivery will be evaluated. Quality is evaluated with a composite criterion comprising 7 elements required for security of anesthesia. Discordance between this composite criterion during the pre anesthesia visit the day of delivery and pre anesthesia consultation several weeks before delivery will be assessed.
详细描述
In the third trimester of pregnancy, pre-anesthetic consultations are mandatory before childbirth, typically recommended between 32 and 36 weeks of gestation. These consultations assess risks associated with anesthesia and childbirth while providing information on anesthetic options, including neuraxial anesthesia. Since 2009, consultations can be conducted on-site or via teleconsultation. However, the quality of teleconsultations and patient satisfaction have not been evaluated in an obstetric context.
This study consists of two patient groups assigned following randomization:
- Teleconsultation: conducted at Bordeaux University Hospital by an obstetric anesthesia physician using the teleconsultation software provided by the hospital.
- In-person consultation: conducted at Bordeaux University Hospital according to the usual procedure.
Following patient enrollment, the follow-up protocol proceeds as outlined below:
- Day -56 to Day -28: Patients with scheduled anesthesia appointments during designated teleconsultation periods are contacted. They are briefed about the study and provided with consent documents via email or in person if they opt to participate.
- Day -56 to Day -10: Upon receipt of signed consent forms, patients undergo randomization. If necessary, their initial appointment is adjusted according to the assigned group. The rescheduled appointment is arranged for the same designated time slot, with timing aligned as closely as possible to the original appointment. For teleconsultation participants, the secretary sends anesthesia-related informational materials and instructions for connecting to the teleconsultation software.
- Day 0: Pre-anesthetic consultations are conducted based on the assigned randomization modality (in-person or teleconsultation).
- Day 14: Satisfaction and transportation modality questionnaires are distributed via email.
- Upon childbirth, a pre-anesthetic visit is conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients scheduled to give birth at the Bordeaux University Hospital, ASA score 1 or 2, for their primary pregnancy, who have booked an anesthesia appointment on one of the half-days when teleconsultation is available in the department
- •Have access to the internet and functional computer equipment (smartphone, computer)
- •Have a valid email address and telephone number
排除标准
- •Minor patient (under 18 years old at the time of inclusion)
- •Individuals not affiliated with or beneficiaries of a social security scheme
- •Patients who do not speak French
- •Persons under legal guardianship
- •Psychiatric conditions that impair the ability to consent to or participate in the study
- •Severe spinal pathology (scoliosis requiring a brace or surgery, ankylosing spondylitis), history of spinal surgery
- •Comorbidities with ASA score ≥3
研究组 & 干预措施
Teleconsultation
Patients randomized in teleconsultation arm.
干预措施: Teleconsultation (Procedure)
In-person consultation
Patients randomized in on-site consultation arm
干预措施: on-site consultation (Procedure)
结局指标
主要结局
Composite quality criterion
时间窗: during pre-anesthetic visit, up to 2 months after inclusion (pre-anesthetic consultation)
The primary endpoint will be the discordance between the pre-anesthetic consultation and the pre-anesthetic visit based on a composite quality criterion comprising 7 elements: * Assessment of difficult intubation, defined as a mouth opening \<35 mm * Description of pre-anesthesia medication reconciliation (except therapeutic adjustments in anticoagulants and antidiabetic treatments) * Anesthetic strategy associated with a documented chronic condition if a specific strategy is needed * Adherence to pre-transfusion assessment protocols * Documentation of hematologic assessment in the 6th month, or prescription of assessment in case of absence * Therapeutic approach in case of anemia described * Criteria of difficulty in performing epidural anesthesia This primary criterion will be assessed at the conclusion of the pre-anesthetic visit.
次要结局
- Patient satisfaction(2 weeks after inclusion (pre-anesthetic consultation))
- Anesthesiologist satisfaction(at inclusion (pre anesthetic consultation))
- Carbon footprint(at inclusion (pre anesthetic consultation))
- missed appointment(at inclusion (pre anesthetic consultation))
- Epidural anesthesia difficult to perform(up to 2 month after inclusion)