Difficult IntubationNCT04783584
Agreement Between Video and In-person Airway Assessment Performed by Anaesthetists in Patients Scheduled for Elective Same-day Gynaecological Procedures
An observational study of Difficult Intubation and Difficult Airway Intubation, run by Michael Ma at 1 site in Ireland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Difficult Intubation, Difficult Airway Intubation
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 1 Dec 2020to 15 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Adult, Older adult
Study population: The population is from patients attending clinic for minor or intermediate gynaecological surgery in the Coombe Women \& Infants University Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
The Coombe Women & Infants University Hospital
Dublin, D08 XW7X
Michael Ma, +353857156584, mikelma@gmail.com
Ruairi Irwin, +353877497263, r.irwin1987@gmail.com
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Difficult Intubation, Difficult Airway Intubation
- Keywords
- Pre-operative airway assessment, Virtual airway assessment, Airway examination, Pre-operative airway examination, Airway Tests, Difficult airway prediction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Dec 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Ma, Coombe Women and Infants University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783584
- Sponsor's protocol ID
- Study No. 25 - 2020
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agreement Between Video and In-person Airway Assessment Performed by Anaesthetists in Patients Scheduled for Elective Same-day Gynaecological Procedures
- ClinicalTrials.gov ID
- NCT04783584
- Acronym / sponsor ID
- Study No. 25 - 2020
- Conditions
- Difficult Intubation, Difficult Airway Intubation
- Keywords
- Pre-operative airway assessment, Virtual airway assessment, Airway examination, Pre-operative airway examination, Airway Tests, Difficult airway prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Michael MaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The population is from patients attending clinic for minor or intermediate gynaecological surgery in the Coombe Women \& Infants University Hospital.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between virtual and in-person airway examinations
Time frame: 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.
1 secondary outcome
Agreement between virtual and in-person airway assessments in suspecting a difficult airway
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Difficult Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruitingObservational study
Sniper Intubation for Training of Undergraduate Medical Student
Intubation;Difficult
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Not yet recruitingObservational study
LeHeR Maneuver vs Sniffing Position During Video Laryngoscopy in Predicted Difficult Airway
Difficult Airway, Difficult Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Intubation and Difficult Airway Intubation, run by Michael Ma at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Ma (+353857156584, mami@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between virtual and in-person airway examinations (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.