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

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.

Study Overview

• Status: Recruiting
• Conditions: Difficult Intubation; Difficult Airway Intubation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Michael Ma; Phone Number: +353857156584; Email: mami@tcd.ie

Study Locations

• Ireland
  • Dublin, Ireland, D08 XW7X
    • Recruiting
    • The Coombe Women & Infants University Hospital
    • Contact: Michael Ma; Phone Number: +353857156584; Email: mikelma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The population is from patients attending clinic for minor or intermediate gynaecological surgery in the Coombe Women & Infants University Hospital.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between virtual and in-person airway examinations	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between virtual and in-person airway assessments in suspecting a difficult airway	To compare the overall airway evaluation between clinicians using the video platform versus in-person assessments as binary outcome - difficult airway suspected or not suspected.	6 months

Collaborators and Investigators

• Sponsor: Michael Ma

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ANTICIPATED): July 31, 2021
• Study Completion (ANTICIPATED): August 15, 2021

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pre-operative airway assessment; Virtual airway assessment; Airway examination; Pre-operative airway examination; Airway Tests; Difficult airway prediction
• Other Study ID Numbers: Study No. 25 - 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No