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临床试验/NCT04783584
NCT04783584Unknown不适用

Agreement Between Video and In-person Airway Assessment Performed by Anaesthetists in Patients Scheduled for Elective Same-day Gynaecological Procedures

Michael Ma1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Agreement between virtual and in-person airway examinations

研究概览

简要总结

During a general anaesthetic, patients cannot breathe on their own and have to be artificially ventilated. This is achieved by connecting the patient's windpipe (trachea) to a ventilator via the use of a plastic tube called an endotracheal tube (ETT). To place this ETT into the patient's trachea, an instrument called a laryngoscope is used to lift the tongue and view the entrance to the trachea. This process is called laryngoscopy. The act of placing this ETT into the trachea is called intubation.

In anticipation of this procedure, the airway is assessed by the anaesthetist before the patient is put to sleep. This airway examination helps predict if the patient's airway will prove to be difficult to intubate. This assessment is usually carried out face to face with the patient.

Since the onset of the COVID 19 pandemic, we have been trying to minimise patient footfall performing anaesthetic assessments before surgery through a video platform. The objective of this study is to compare these video airway evaluations to assessments carried out face to face.

We anticipate that the virtual airway assessments will be similar if not the same as the in-person airway assessments.

详细描述

This is a prospective observational study. We are comparing the agreement between a virtual video airway evaluation and an inpatient person-to-doctor airway assessment.

Patients will be referred for virtual preoperative assessment clinic by the gynaecology outpatient department based on inclusion criteria and a patient information leaflet and consent form is supplied at this time. During the virtual assessment consent is taken, followed by a standard history and airway examination. The airway assessment will be performed by an investigator of >5 years anaesthetic experience and will have to undergo a standardised airway assessment training. This airway evaluation is also documented separate to the remainder of the history, sealed in an envelope and labelled a designated number. On the date of surgery, the patient is assessed again by an investigator in the ward/theatre prior to surgery. This airway examination is documented on the standard anaesthetic record sheet as well as on a separate in-person evaluation form. This airway assessment form is then sealed in an envelope and labelled the same designated number as the virtual assessment. The evaluations will be entered into a database and analysed.

If the evaluation is found to show predictors of a difficult airway in the virtual clinic, the patient is scheduled for an in-person outpatient appointment. The airway is then assessed by an investigator in-person at the clinic. The airway is then assessed by an anaesthetic consultant and documented on the anaesthetic record sheet. Investigators will have no further involvement in the clinical management of the patient.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • We will include patients attending clinic for minor or intermediate gynaecological surgery who were ASA physical status 1-2, BMI less than 40, greater than 18 and less than 65 years of age and no language barrier.

排除标准

  • We excluded anyone over 65 years of age, with a BMI over 40, ASA physical status over 2, undergoing major gynaecological surgery, requiring translation services or difficulty accessing virtual technology.

结局指标

主要结局

Agreement between virtual and in-person airway examinations

时间窗: 6 months

To determine whether the airway assessment via a virtual platform is in agreement with an in-person airway examination in patients scheduled for elective day-surgery procedures.

次要结局

  • Agreement between virtual and in-person airway assessments in suspecting a difficult airway(6 months)

研究者

发起方
Michael Ma
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Ma

Locum Consultant

Coombe Women and Infants University Hospital

研究点 (1)

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