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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.
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Scientific title
Laryngoscope-Bougie Guided i-gel Insertion in Difficult Airways: A Feasibility Trial
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Secondary ID [1]
310612
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Airway features difficult for supraglottic device insertion
331492
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Condition category
Condition code
Anaesthesiology
328227
328227
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0
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Anaesthetics
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Emergency medicine
328228
328228
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0
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Other emergency care
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
327017
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Treatment: Other
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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First attempt success at i-gel insertion
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Assessment method [1]
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Passage into the oropharynx, or 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 criteria for sustained exhaled CO2 met: levels rising during exhalation and falling during inspiration; consistent or increasing amplitude over seven breaths, and a peak amplitude >7.5 mmHg above baseline.
The end-tidal CO2 waveform and scale will be displayed on the monitor of the anaesthetic ventilator. The end-tidal CO2 values will be recorded and uploaded to the hospital's Digital Health Record, as is standard practice for all anaesthetics at the hospital in which this trail is taking place.
The outcome will be recorded using Research Electronic Data Capture, a web-based electronic data capture tool used to support clinical and research studies.
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Timepoint [1]
336093
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Single time point, success of intervention evaluated at time of insertion
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Secondary outcome [1]
426823
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Airway trauma
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Assessment method [1]
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Visible blood staining on the bougie, laryngoscope or i-gel on device removal.
The outcome will be recorded using Research Electronic Data Capture, a web-based electronic data capture tool used to support clinical and research studies.
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Timepoint [1]
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Single time point, success of intervention evaluated at time of device removal
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Secondary outcome [2]
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Post-operative sore throat
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Assessment method [2]
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Patient-reported scale of mild (score of 1), moderate (score of 2), or severe (score of 3)
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Timepoint [2]
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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.
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Secondary outcome [3]
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Consultant anaesthetist feedback of laryngoscope-bougie guided i-gel insertion for patients with risk factors for difficult supraglottic airway insertion.
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Assessment method [3]
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Question 1: Have you previously used laryngoscope-bougie guided insertion for supraglottic airway devices?
Question 2: How did you find the experience of laryngoscope-bougie guided insertion of the i-gel?
Question 3: Do you have any concerns regarding the technique of laryngoscope-bougie guided insertion of supraglottic airway devices?
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Timepoint [3]
426825
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Immediately post anaesthetic induction, once confirmation of patient stability is confirmed by the attending consultant anaesthetist
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Secondary outcome [4]
426826
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Time taken to complete laryngoscope-bougie guided insertion of the i-gel
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Assessment method [4]
426826
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Time between picking up the laryngoscope or the lubricated bougie and an end-tidal Co2 trace being generated. This will be measured using the anaesthetic machine stopwatch feature.
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Timepoint [4]
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Upon end-tidal CO2 trace being generated
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2024
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Actual
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Date of last participant enrolment
Anticipated
29/02/2024
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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The Canberra Hospital
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Address [1]
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Yamba Dr, Garran ACT 2605
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
The Canberra Hospital
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Address
Yamba Dr, Garran ACT 2605
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Country
Australia
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Secondary sponsor category [1]
316817
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None
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Name [1]
316817
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Address [1]
316817
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Country [1]
316817
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
313831
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The ACT Health Human Research Ethics Committee
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Ethics committee address [1]
313831
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Yamba Drive, Garran ACT 2605
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Ethics committee country [1]
313831
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Australia
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Date submitted for ethics approval [1]
313831
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01/12/2023
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Approval date [1]
313831
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Ethics approval number [1]
313831
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Summary
Brief summary
Commonly used airway devices during general anaesthesia include supraglottic airway devices, of which best practice involves minimising the number of attempts at airway insertion to reduce patient morbidity. The intervention of this study involves the use of two additional pieces of airway equipment, a laryngoscope and bougie, to guide supraglottic guide insertion. The hypothesis is that this insertion method will increase the first attempt insertion success rate.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jonathan Shachar
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Address
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The Canberra Hospital, Yamba Dr, Garran ACT 2605
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Country
129482
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Australia
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Phone
129482
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+61 2 5124 0000
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Fax
129482
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Email
129482
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[email protected]
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Contact person for public queries
Name
129483
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Dr Jonathan Shachar
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Address
129483
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The Canberra Hospital, Yamba Dr, Garran ACT 2605
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Country
129483
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Australia
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Phone
129483
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+61 2 5124 0000
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Fax
129483
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Email
129483
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[email protected]
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Contact person for scientific queries
Name
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Dr Jonathan Shachar
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Address
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The Canberra Hospital, Yamba Dr, Garran ACT 2605
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Country
129484
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Australia
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Phone
129484
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+61 2 5124 0000
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Fax
129484
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Email
129484
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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