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Trial registered on ANZCTR


Registration number
ACTRN12623001232628p
Ethics application status
Not yet submitted
Date submitted
13/10/2023
Date registered
30/11/2023
Date last updated
30/11/2023
Date data sharing statement initially provided
30/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of a laryngoscope and bougie increase i-gel insertion success in patients with difficult airway features.
Scientific title
Laryngoscope-Bougie Guided i-gel Insertion in Difficult Airways: A Feasibility Trial
Secondary ID [1] 310612 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Airway features difficult for supraglottic device insertion 331492 0
Condition category
Condition code
Anaesthesiology 328227 328227 0 0
Anaesthetics
Emergency medicine 328228 328228 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The drain tube of the i-gel (2nd generation supra-glottic airway device, made by Intersurgical) will be primed with a 14 French lubricated bougie (Frova Intubating Introducer, Cook Medical) with its straight end first, leaving the 5-cm bent portion protruding from the proximal end (for the airway assistant to grip), and the maximum length protruding from the distal end for the anaesthetist to manipulate. The posterior glottis will be identified under direct vision with a size 3 Macintosh laryngoscope (Koala Medical), with the distal portion of the bougie advanced in the midline, 5–10 cm into the oesophagus while the assistant holds the i-gel (Intersurgical) and the proximal portion. The laryngoscope will be removed with the i-gel inserted using a rotational insertion technique while the assistant stabilises the proximal end of the bougie, so it does not penetrate further into the oesophagus. The steps of rotational insertion will include: insertion of the entire cuff of the i-gel into the mouth in a midline approach without finger insertion; rotated 90° counter clockwise around the tongue; advanced until resistance is felt at the hypopharynx; then re-rotated clockwise to the standard orientation. The bougie will be removed while i-gel is held in position. If adequate ventilation does not occur, up to three minor airway interventions will be performed (adjusting head/neck position, jaw thrust, digital traction on the tongue, or changing depth of i-gel insertion).

Adequacy of ventilation will be defined as: ability to ventilate with a tidal volume of at least 6 ml per kg of Ideal Body Weight with an end tidal-CO2 of < 45mmHg, with the following 3 criteria for sustained exhaled CO2 met:
1) Levels rising during exhalation and falling during inspiration
2) Consistent or increasing amplitude over seven breaths
3) End tidal -Co2 peak amplitude >7.5 mmHg above baseline

A document outlining the steps and requirements of this intervention will be provided to the anaesthetist to guide their practice. An investigator will be present to clarify any queries.
Intervention code [1] 327017 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336093 0
First attempt success at i-gel insertion
Timepoint [1] 336093 0
Single time point, success of intervention evaluated at time of insertion
Secondary outcome [1] 426823 0
Airway trauma
Timepoint [1] 426823 0
Single time point, success of intervention evaluated at time of device removal
Secondary outcome [2] 426824 0
Post-operative sore throat
Timepoint [2] 426824 0
Time point 1: In the Post Anaesthesia Care Unit once the patient has achieved a value of less than or equal to 3 on the Ramsay Sedation Score.
Time point 2: 4 hours post-surgery.
Secondary outcome [3] 426825 0
Consultant anaesthetist feedback of laryngoscope-bougie guided i-gel insertion for patients with risk factors for difficult supraglottic airway insertion.
Timepoint [3] 426825 0
Immediately post anaesthetic induction, once confirmation of patient stability is confirmed by the attending consultant anaesthetist
Secondary outcome [4] 426826 0
Time taken to complete laryngoscope-bougie guided insertion of the i-gel
Timepoint [4] 426826 0
Upon end-tidal CO2 trace being generated

Eligibility
Key inclusion criteria
1. Elective non-head and neck surgery in the supine position
2. Body Mass Index greater than 30 kg/m2
3. Age greater than or equal to 18 years old
At least 1 of the following:
1. Poor dentition, defined as partial dentures, loose, or broken teeth.
2. Reduced cervical spine range of motion, defined as less than 90° of flexion or less than 70° of extension.
3. Thyromental distance less than 6cm.
4. Limited mandibular protrusion or retrognathia: defined as ability to protrude upper incisors no further than being in line with the lower incisors.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Procedures where paralysis is necessary to facilitate surgery.
2. Anticipated surgery duration of greater than 2 hours.
3. Patients at high risk of aspiration:
3a. Unfasted as per American Society of Anaesthesiologists: nil clear liquids for greater than 2 hours, toast greater than 6 hours, meat or fried/fatty foods greater than 8 hours.
3b. Active gastroesophageal reflux symptoms despite fasting and/or pharmacological treatment, defined as: belching, dyspepsia, or heartburn.
3c. Bowel obstruction or haematemesis
4. Known distorted airway anatomy (for example from imaging or a documented history)
5. Sore throat on day of surgery or known structural oesophageal disease.
6. Severe ventilatory disease confirmed by spirometry: Forced expiratory volume in one second of less than 50% of predicted
7. History of inability to bag mask ventilation (with or without oropharyngeal or nasopharyngeal device, and/or positive end expiratory pressure)
8. History of documented difficult intubation or a Cormack-Lehane laryngoscopy score of IIIa or above.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 314825 0
Hospital
Name [1] 314825 0
The Canberra Hospital
Country [1] 314825 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
Yamba Dr, Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 316817 0
None
Name [1] 316817 0
Address [1] 316817 0
Country [1] 316817 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313831 0
The ACT Health Human Research Ethics Committee
Ethics committee address [1] 313831 0
Ethics committee country [1] 313831 0
Australia
Date submitted for ethics approval [1] 313831 0
01/12/2023
Approval date [1] 313831 0
Ethics approval number [1] 313831 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129482 0
Dr Jonathan Shachar
Address 129482 0
The Canberra Hospital, Yamba Dr, Garran ACT 2605
Country 129482 0
Australia
Phone 129482 0
+61 2 5124 0000
Fax 129482 0
Email 129482 0
[email protected]
Contact person for public queries
Name 129483 0
Jonathan Shachar
Address 129483 0
The Canberra Hospital, Yamba Dr, Garran ACT 2605
Country 129483 0
Australia
Phone 129483 0
+61 2 5124 0000
Fax 129483 0
Email 129483 0
[email protected]
Contact person for scientific queries
Name 129484 0
Jonathan Shachar
Address 129484 0
The Canberra Hospital, Yamba Dr, Garran ACT 2605
Country 129484 0
Australia
Phone 129484 0
+61 2 5124 0000
Fax 129484 0
Email 129484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.