NCT04783584

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 2, 2021

Last Update Submit

March 2, 2021

Conditions

Keywords

Pre-operative airway assessmentVirtual airway assessmentAirway examinationPre-operative airway examinationAirway TestsDifficult airway prediction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Agreement between virtual and in-person airway assessments in suspecting a difficult airway

    6 months

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study includes patients going for gynaecological procedures and as such only pertains to the female gender
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Coombe Women & Infants University Hospital

Dublin, D08 XW7X, Ireland

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Locum Consultant

Study Record Dates

First Submitted

March 2, 2021

First Posted

March 5, 2021

Study Start

December 1, 2020

Primary Completion

July 31, 2021

Study Completion

August 15, 2021

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations