Quality of Preanesthesia Teleconsultation Versus Preanesthesia Traditional Consultation : a Randomized Controlled Equivalence Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 主要终点
- Agreement concerning the risk of difficult intubation between preanesthesia consultation and visit.
研究概览
简要总结
Since the publication of the law " Hôpital, Patients, Santé, Territoire " of 2009 in France, the development of telemedicine is a public health issue. It is also a government priority registered in the government investment plan of 2017-2018.
The quality of preanesthesia teleconsultation at home, through video-conference, has never been tested in practice.The aim of this study is to evaluate the quality of preanesthesia teleconsultations through video-conference, compared with traditional preanesthesia consultations. The quality is established by the assessment of the primary outcome : the risks related to difficult intubation, in patients undergoing ambulatory surgery at the Surgical Center Emile Galle. Our research hypothesis is that there is no difference between the quality of preanesthesia teleconsultations through video-conference, and the quality of traditional preanesthesia consultations. Secondary objectives are to identify satisfaction and preoperative anxiety of patients regarding teleconsultation, to identify satisfaction of practioners regarding teleconsultation, to evaluate the quality (based on the assessment of secondary outcomes) of preanesthesia teleconsultations compared with traditional preanesthesia consultations, and to evaluate the technical viability of generalising preanesthesia teleconsultation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participant and care provider know the allocation group "teleconsultation" or "traditional consultation".
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with social security affiliation.
- •Informed consent from patient
- •Patient with an ambulatory surgery programmed in the surgical center Emile Galle (CHRU de Nancy)
- •Patient with technology equipments, which are compatible with the plateform of video-conference :
- •smartphones, touch pads, computer
- •web-browser ( chrome or internet explorer)
- •Webcam and microphone
排除标准
- •Patients covered by Articles L. 1121-5 to L. 1121-8, L1122-2 and L. 1122-1-2 of the french public health code. (Persons especially protected by Act)
- •Patients refusing to participate to the study, or refusing the randomization for the group allocation.
- •Preanesthesia consultation for a programmed surgery in an hospital other than the surgical center of Emile Galle.
研究组 & 干预措施
Preanesthesia teleconsultation
Preanesthesia teleconsultation through video-conference, between an anesthesiologist of the surgical center Emile Galle, in a medical consulting room in the surgical center Emile Galle, and a patient at home or at work. The patient must be in a quiet area, which allows the confidential medical contact.
干预措施: preanesthesia teleconsultation (Procedure)
Preanesthesia traditional consultation
Preanesthesia traditional consultation between an anesthesiologist of the surgical center Emile Galle, and a patient, in a medical consulting room in the surgical center Emile Galle.
干预措施: preanesthesia traditional consultation (Procedure)
Bis traditional consultation
If a patient, in the group " preanesthesia teleconsultation " cannot realized his teleconsultation because of technical problem, he will be assigned on the sub group " bis traditional preanesthesia consultation ".
干预措施: preanesthesia traditional consultation (Procedure)
结局指标
主要结局
Agreement concerning the risk of difficult intubation between preanesthesia consultation and visit.
时间窗: 1 day before surgery or baseline (J0 = surgery day)
The quality of a preanesthesia consultation (teleconsultations or traditional consultations) is considered to be correct when the result (presence or lack of difficult intubation risks) is consistent with the result of the preanesthesia visit (before surgery.) If yes from 2 of the 4 following propositions about predictable intubation difficulty ( mallampi score \> II (yes/no), previous difficult intubation (yes/no), oral opening \<30mm (yes/no), distance thyro-mentonnière \< 65mm. (yes/no)), the predictable intubation will be difficult.
次要结局
- Satisfaction of patient(1 day before surgery or baseline (J0 = surgery day))
- Agreement between preanesthesia consultation and visit concerning the evaluation of "American Society of Anesthesiologists" (ASA) score of the patient(1 day before surgery or baseline (J0 = surgery day))
- Satisfaction of anesthesiologist(1 day before surgery or baseline (J0 = surgery day))
- Preoperative anxiety of patient(1 day before surgery or baseline (J0 = surgery day))
- Calculation of a ratio to evaluate the technical viability of generalising preanesthesia teleconsultation(1 day before surgery or baseline (J0 = surgery day))
- Agreement between preanesthesia consultation and visit concerning the risk of difficult mask ventilation(1 day before surgery or baseline (J0 = surgery day))
- Agreement between preanesthesia consultation and visit concerning correct treatment management.(1 day before surgery or baseline (J0 = surgery day))
- Agreement between preanesthesia consultation and visit concerning completeness of preoperative workup(1 day before surgery or baseline (J0 = surgery day))