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临床试验/NCT06765538
NCT06765538招募中不适用

Video Versus Face-to-face Preoperative Anaesthetic Assessment: a Randomized Clinical Trial on Safety and User Satisfaction

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 2,260 人开始时间: 2024年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,260
试验地点
2
主要终点
SAE

研究概览

简要总结

Randomized clinical trial rewieving difference between anaesthetic preassessment in physical consultations vs. video consultations.

详细描述

Preoperative anaesthetic assessment aims to reduce morbidity and mortality and are currently accepted as the gold standard of care for elective surgery. Technical advances in society have led to explora-tions within the telemedicine area which continues providing safe and effective services. The video versus face-to-face preoperative anaesthetic assessment (VIDFACE) trial aims to compare videobased preoperative anaesthetic assessment to standard face-to-face consultations with focus on patient safety and satisfaction including possible beneficial eco and economical effects compared to standard face-to-face consultations.

This is a randomised, single-centre, two-arm, assessor, and data analyst blinded clinical trial. We will enrol 2260 participants undergoing elective Ear-Nose-Throat or Tooth-Mouth-Jaw surgery. Participants will be randomised 1:1 stratified by malignant versus benign surgery to either video based preoperative anaesthetic assessment or face-to-face consultation. Data will be analysed by two blinded statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind.

Results:

The primary outcome is the incidence of six predefined serious adverse events (SAE). Secondary outcomes are the proportion of participant with a change in anaesthesia plan as well as delays or cancellations on the day of surgery and patient satisfaction.

The VIDFACE trial will contribute valuable knowledge on the efficacy and safety on using video consultations in the an-aesthetic preoperative assessment.

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ENT and TMJ patients
  • Adults > 18 years
  • Informed consent obtained after a consideration period of minimum 24 hours

排除标准

  • If a patient is assessed unsuitable for the video technology in example, patients with severe mental challenges (dementia, retardation, etc.), they will not be included in the trial. If excluded, the patient receives standard care, face-to-face preoperative anaesthetic assessment.
  • Local protocol screen patients

结局指标

主要结局

SAE

时间窗: 30 day follow up

All-cause mortality, all-cause admission to intensive care unit, bleeding requiring transfusion, infection requiring antibiotics, hospital readmission or prolonged hospitalization.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katrine Bredahl Buggeskov

Principal Investigator

Rigshospitalet, Denmark

研究点 (2)

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