AnesthesiaNCT02663843
Low Skill Fibreoptic Intubation I-gel vs Air-Q
A study testing i-gel airway and air-Q airway in people with Anesthesia, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Tracheal intubation under general anaesthesia is the gold standard for securing the airway and for protecting the lungs against gastric aspiration. The conventional technique involves the use of a metal laryngoscope inserted into the mouth to create an air space, to allow insertion of an endotracheal tube. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- i-gel airway and air-Q airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2017to 1 Jun 2017
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a physical status of American Society of Anesthesiologists (ASA) grade I/II and over 21 years old, having elective surgery, who require endotracheal intubation
Who cannot join
- ASA class III/IV
- Patients with history of previous difficult endotracheal intubation
- Patients with two or more predictors of difficult airway management (criteria 1-8, below)
- Airway masses
- Mallampati (oropharygneal space grading) III or IV
- Thyromental distance < 6.5cm
Show all 13Show fewer
- Inter-incisor distance < 3 cm
- Head extension < 30 degrees
- Edentulous
- Large beard
- Obstructive sleep apnoea (OSA) or snorer
- Patients needing a rapid sequence induction
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospitals
Singapore, 169608
Patrick Wong, FRCA, 63214220, patrick.wong@singhealth.com.sg
About this study
Official title: Comparison of 'Low Skill Fibreoptic Tracheal Intubation' Via I-gel® and Air-Q® Supraglottic Airway Devices in Patients With Simulated Difficult Airways.
Tracheal intubation under general anaesthesia is the gold standard for securing the airway and for protecting the lungs against gastric aspiration. The conventional technique involves the use of a metal laryngoscope inserted into the mouth to create an air space, to allow insertion of an endotracheal tube.
Alternatively, an oral airway device (called a supraglottic device (SGD)) can be used for tracheal intubation. The SGD is first inserted. A fibrescope is inserted down the shaft of the SGD and into the trachea. This allows an endotracheal tube (previously pre-loaded onto the fibrescope) to be railroaded of the fibrescope and into the trachea. This technique is called 'low skill fibreoptic intubation' as the SGD acts as a guide for the fibrescope. Our study compares the performance of two SGD: i-gel and air-Q. The investigators will compare intubation success rate, insertion rate, and times for SGD insertion and intubation.
Read the detailed description
The investigators are testing to see if fibreoptic intubation in patients via a supraglottic airway device i.e. 'low skill fibreoptic intubation' (LSFOI) is more successful via the i-gel® than in the air-Q®. Patients are those scheduled for elective surgery under general anaesthesia who would normally require tracheal intubation. The investigator's hypothesis is based on the results of the investigator's recent manikin study (CIRB 2014/2039). The investigators would like to see if this hypothesis translates to patients. It will also test secondary outcomes e.g. SGD insertion success rates and times, and intubation times. In the aforementioned manikin study, the air-Q® performed better with the SGD insertion rates and times. However, the i-gel® performed better with intubation success rates and times. The devices may perform different due to differences between the devices: design (shape, volume, length, aperture), material composition, and technique required for insertion and intubation.
24 adult patients undergoing elective surgery requiring general anaesthesia and endotracheal intubation in the major operating theater of Singapore General Hospital will be enrolled. The patient will then be randomised in equal proportions into two groups, either the air-Q® or i-gel®. Patients will undergo induction of general anaesthesia in a standardised fashion and in accordance with usual practice in the investigator's department of anaesthesia. Intubation will then proceed with the assigned airway device. Data collected will include successful endotracheal intubation, as evidenced by the presence of end tidal carbon dioxide on a capnograph. Time to intubation (from the initial handling of the airway device until successful intubation is confirmed with successful lung ventilation), the number of attempts required and the view achieved (according to the modified Cormack and Lehane scoring system) will also be recorded. Injuries to the lips, teeth or upper airway will be sought and documented by a blinded observer in the Post Anesthetic Care Unit.
A protocol will be provided to standardise the induction of general anaesthesia. This will involve the application of standard patient monitors, a period of pre-oxygenation, and administration of anaesthetic agents and muscle relaxants. If the patient desaturates to SpO2 < 94% during intubation, the intubation attempt via either the air-Q® or i-gel® will be abandoned and intubation will proceed using the conventional direct laryngoscope.
- Conditions
- Anesthesia
- Being tested
- i-gel airway, air-Q airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gel airwayDevice
Fibreoptic intubation via i-gel airway device
air-Q airwayDevice
Fibreoptic intubation via air-Q airway device
| Study group | Role | What they receive |
|---|---|---|
| i-gel airway | Experimental | I-gel inserted for the low skill fibreoptic intubation technique Receives: Device: i-gel airway |
| air-Q airway | Experimental | Air-Q inserted for the low skill fibreoptic intubation technique Receives: Device: air-Q airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of low skill fibreoptic intubation using the i-gel or air-Q airway devices measured end tidal carbon dioxide levels
Successful intubation indicated by normal end tidal carbon dioxide levels and trace
Measured: 3 minutes
Secondary outcomes (3)
Airway device insertion times
Time from picking up device to obtaining adequate canpography tracing
Measured: 3 minutes
Low skill fibreoptic intubation times
Time from picking up fibrescope to obtaining adequate canpography tracing
Measured: 3 minutes
Complication rate
Complications due to airway and fiberscope insertion and use
Measured: Time of intubation and up to one day postoperative recovery period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start1 Jan 2017
- Primary completion1 Jun 2017 (estimated)
- Study completion1 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wong, Patrick, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663843
- Sponsor's protocol ID
- 1601LSFOI
- Status last verified
- Apr 2017
- First submitted
- 18 Jan 2016
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
de Lloyd LJ, Subash F, Wilkes AR, Hodzovic I. A comparison of fibreoptic-guided tracheal intubation through the Ambu (R) Aura-i , the intubating laryngeal mask airway and the i-gel : a manikin study. Anaesthesia. 2015 May;70(5):591-7. doi: 10.1111/anae.12988. Epub 2015 Jan 29.
PubMed 25631299Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q((R)) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100. doi: 10.1111/j.1365-2044.2011.06863.x. Epub 2011 Aug 22.
PubMed 21880031Moon HS, Lee JY, Chon JY, Lee H, Kim D. Air-Q(R)sp-assisted awake fiberoptic bronchoscopic intubation in a patient with Ludwig's angina. Korean J Anesthesiol. 2014 Dec;67(Suppl):S23-4. doi: 10.4097/kjae.2014.67.S.S23. No abstract available.
PubMed 25598892
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 'Low Skill Fibreoptic Tracheal Intubation' Via I-gel® and Air-Q® Supraglottic Airway Devices in Patients With Simulated Difficult Airways.
- ClinicalTrials.gov ID
- NCT02663843
- Acronym / sponsor ID
- 1601LSFOI
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2017 (estimated)
- Study completion
- 1 Jun 2017 (estimated)
- First posted
- 26 Jan 2016 (estimated)
- 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.
Tracheal intubation under general anaesthesia is the gold standard for securing the airway and for protecting the lungs against gastric aspiration. The conventional technique involves the use of a metal laryngoscope inserted into the mouth to create an air space, to allow insertion of an endotracheal tube.
Alternatively, an oral airway device (called a supraglottic device (SGD)) can be used for tracheal intubation. The SGD is first inserted. A fibrescope is inserted down the shaft of the SGD and into the trachea. This allows an endotracheal tube (previously pre-loaded onto the fibrescope) to be railroaded of the fibrescope and into the trachea. This technique is called 'low skill fibreoptic intubation' as the SGD acts as a guide for the fibrescope. Our study compares the performance of two SGD: i-gel and air-Q. The investigators will compare intubation success rate, insertion rate, and times for SGD insertion and intubation.
Detailed description
The investigators are testing to see if fibreoptic intubation in patients via a supraglottic airway device i.e. 'low skill fibreoptic intubation' (LSFOI) is more successful via the i-gel® than in the air-Q®. Patients are those scheduled for elective surgery under general anaesthesia who would normally require tracheal intubation. The investigator's hypothesis is based on the results of the investigator's recent manikin study (CIRB 2014/2039). The investigators would like to see if this hypothesis translates to patients. It will also test secondary outcomes e.g. SGD insertion success rates and times, and intubation times. In the aforementioned manikin study, the air-Q® performed better with the SGD insertion rates and times. However, the i-gel® performed better with intubation success rates and times. The devices may perform different due to differences between the devices: design (shape, volume, length, aperture), material composition, and technique required for insertion and intubation.
24 adult patients undergoing elective surgery requiring general anaesthesia and endotracheal intubation in the major operating theater of Singapore General Hospital will be enrolled. The patient will then be randomised in equal proportions into two groups, either the air-Q® or i-gel®. Patients will undergo induction of general anaesthesia in a standardised fashion and in accordance with usual practice in the investigator's department of anaesthesia. Intubation will then proceed with the assigned airway device. Data collected will include successful endotracheal intubation, as evidenced by the presence of end tidal carbon dioxide on a capnograph. Time to intubation (from the initial handling of the airway device until successful intubation is confirmed with successful lung ventilation), the number of attempts required and the view achieved (according to the modified Cormack and Lehane scoring system) will also be recorded. Injuries to the lips, teeth or upper airway will be sought and documented by a blinded observer in the Post Anesthetic Care Unit.
A protocol will be provided to standardise the induction of general anaesthesia. This will involve the application of standard patient monitors, a period of pre-oxygenation, and administration of anaesthetic agents and muscle relaxants. If the patient desaturates to SpO2 < 94% during intubation, the intubation attempt via either the air-Q® or i-gel® will be abandoned and intubation will proceed using the conventional direct laryngoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-gel airway | Experimental | Device: i-gel airwayI-gel inserted for the low skill fibreoptic intubation technique |
| air-Q airway | Experimental | Device: air-Q airwayAir-Q inserted for the low skill fibreoptic intubation technique |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a physical status of American Society of Anesthesiologists (ASA) grade I/II and over 21 years old, having elective surgery, who require endotracheal intubation
Key exclusion criteria (13 listed)
- ASA class III/IV
- Patients with history of previous difficult endotracheal intubation
- Patients with two or more predictors of difficult airway management (criteria 1-8, below)
- Patients needing a rapid sequence induction
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-gel airwayFibreoptic intubation via i-gel airway device | Device | i-gel airway |
| air-Q airwayFibreoptic intubation via air-Q airway device | Device | air-Q airway |
Primary outcome
Success of low skill fibreoptic intubation using the i-gel or air-Q airway devices measured end tidal carbon dioxide levels
Time frame: 3 minutes
Successful intubation indicated by normal end tidal carbon dioxide levels and trace
3 secondary outcomes
Airway device insertion times
Time frame: 3 minutes
Low skill fibreoptic intubation times
Time frame: 3 minutes
Complication rate
Time frame: Time of intubation and up to one day postoperative recovery period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Background: PubMed 25631299de Lloyd LJ, Subash F, Wilkes AR, Hodzovic I. A comparison of fibreoptic-guided tracheal intubation through the Ambu (R) Aura-i , the intubating laryngeal mask airway and the i-gel : a manikin study. Anaesthesia. 2015 May;70(5):591-7. doi: 10.1111/anae.12988. Epub 2015 Jan 29.
- Background: PubMed 21880031Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q((R)) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100. doi: 10.1111/j.1365-2044.2011.06863.x. Epub 2011 Aug 22.
- Background: PubMed 25598892Moon HS, Lee JY, Chon JY, Lee H, Kim D. Air-Q(R)sp-assisted awake fiberoptic bronchoscopic intubation in a patient with Ludwig's angina. Korean J Anesthesiol. 2014 Dec;67(Suppl):S23-4. doi: 10.4097/kjae.2014.67.S.S23. No abstract available.
- Individual participant dataSharing planned: No
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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.
Patrick Wong, Patrick principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-gel airway and air-Q airway in people with Anesthesia, run by Singapore General Hospital at 1 site in Singapore.
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 13 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 1 May 2017. 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 Singapore. 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 Patrick Wong, MBBS FRCA (+6563214220, Patrick.Wong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of low skill fibreoptic intubation using the i-gel or air-Q airway devices measured end tidal carbon dioxide levels (time frame: 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663843, which also lists 3 linked publications.
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 1 May 2017.