Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal TubePhase 4NCT01906060
Blind Intubation Through The Self-Pressurised Disposable Air-Q Laryngeal Intubation Mask: An International Multicentre Trial
A Phase 4 study testing Air-Q Intubation Laryngeal Mask in people with Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube, run by University of Zurich at 3 sites in 2 countries.
Trial summary
The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical, Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a tracheal tube. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube
- What is being tested?
- Air-Q Intubation Laryngeal Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2013to Jun 2016
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective surgery requiring tracheal intubation using an oral tracheal tube
- anticipated extubation in the operating room
- American Society of Anaesthesiologist Physical Status 1-3
- age = 18 years and = 85 years
- oral and written informed consent
- weight = 100kg (according to the product description)
- ability to understand the study information
Who cannot join
- pharyngeal, laryngeal or tracheal pathology, including tracheostomy
- mouth opening < 2.5 cm
- any form of airway infection such as upper-respiratory tract infection, pneumonia or suspected tuberculosis
- any disease that might impair the power of judgement (psychiatric disease, dementia)
- indicated rapid sequence induction which is a standard when high risk for regurgitation and/or aspiration is present
- the subject must not be involved in any other clinical trial during the course of this trial, nor within a period of 30 days prior to its beginning or 30 days after its completion
- pregnancy
- breast feeding
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
KantonsSpital Winterthur
Winterthur, 8401
University Hospital Zurich, Institute of Anaesthesiology
Zurich, Canton of Zurich, 8091
About this study
The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical, Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a tracheal tube. This intubating laryngeal airway device (ILA) is already commercially available and worldwide certificated (CE 0482), but data about the success rates of blind intubation via this device in adult patients are lacking. Success rates of blind intubations with the non-self-inflating device range between 57 and 97%.
Although the self-inflating disposable Air-Q device is certified for blind intubation, the success rate and rate of adverse events associated with this procedure have not been published so far. In a study comparing adverse events of conventional intubation with blind intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One study using the self-pressurised disposable Air-Q for ventilation of children showed broncho- or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat were reported in 1%.
Read more
This data suggests that the rate of adverse events using the Air-Q supra-glottic device are comparable to other devices such as LMA.
- Trial with medical device
- Being tested
- Air-Q Intubation Laryngeal Mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air-Q Intubation Laryngeal MaskDevice
Patients will be intubated using the Air-Q Laryngeal Mask.
| Study group | Role | What they receive |
|---|---|---|
| Air-Q Intubation Laryngeal Mask | Experimental | Patients will be intubated using the Air-Q Intubation Laryngeal Mask and subsequently intubated with a commercially available endotracheal tube via the Intubation Laryngeal Mask. Receives: Device: Air-Q Intubation Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of blind intubation via the disposable Air-Q self-inflating laryngeal intubation mask.
Success is defined as placement of a tracheal tube into trachea with no more than two insertion attempts.
Measured: 300 seconds
Secondary outcomes (16)
Time for insertion of the Air-Q laryngeal mask
defined as time beginning at the moment the ILA enters the mouth until the appearance of the capnography waveform
Measured: 300 seconds
Time for insertion of the tube
defined as the time beginning at the moment of insertion of the tube through the laryngeal mask until the appearance of the capnography waveform
Measured: 300 seconds
First attempt rate and second attempt rate
Measured: 300 seconds
Time for removal of the Air-Q ILA device after successful intubation
Measured: 500 seconds
Rate of misplacement of the ILA
Measured: 300 seconds
Rate of misplacement of the tube
Measured: 500 seconds
risk factors of insertion failures
Measured: 500 seconds
Rate of airway injuries
Measured: 5 hours
Tightness during leak test before relaxation
Measured: 300 seconds
Tightness during leak test after relaxation
Measured: 300 seconds
Maximum drop of saturation during airway management
Measured: 500 seconds
Rate of adverse events
including, but not limited to suspicion of aspiration or regurgitation (gastric fluid in the ventilation tube or hypopharynx), bronchospasm, airway obstruction, coughing, dental-, tongue-, lip- pharyngeal or laryngeal trauma
Measured: 5 hours
Rate of necessity of alternative airway device
Measured: 500 seconds
Rate of blood stained devices after removal of the ILA
Measured: 500 seconds
Postoperative coughing after 2 hours and the next morning
Measured: 24 hours
Postoperative hoarseness after 2 hours and the next morning
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal TubeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donat R. Spahn, Prof MD, Principal investigator, University Hospital Zurich, Institute of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906060
- Sponsor's protocol ID
- 2013-0151
- Status last verified
- Jun 2016
- First submitted
- 18 Jul 2013
- Last updated
- 29 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blind Intubation Through The Self-Pressurised Disposable Air-Q Laryngeal Intubation Mask: An International Multicentre Trial
- ClinicalTrials.gov ID
- NCT01906060
- Acronym / sponsor ID
- 2013-0151
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Jul 2013 (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.
The disposable Air-Q self-inflating laryngeal intubation mask (Air-Q, Mercury Medical, Clearwater, FL, USA) is an extra-glottic airway device which enables blind intubation with a tracheal tube. This intubating laryngeal airway device (ILA) is already commercially available and worldwide certificated (CE 0482), but data about the success rates of blind intubation via this device in adult patients are lacking. Success rates of blind intubations with the non-self-inflating device range between 57 and 97%.
Although the self-inflating disposable Air-Q device is certified for blind intubation, the success rate and rate of adverse events associated with this procedure have not been published so far. In a study comparing adverse events of conventional intubation with blind intubation via a different supra-glottic airway device (ILMA) the rates of sore throat and cough were comparable in both groups and were reported in 10-17% of the patients. In a pilot study using the non-self-inflating Air-Q for blind intubation in 19 patients, 10% reported dysphagia and one patient had a bilateral lingual nerve injury which was self-limited. One study using the self-pressurised disposable Air-Q for ventilation of children showed broncho- or laryngospasm in 3% and mucosal damage such as blood stained ILA or sore throat were reported in 1%.
This data suggests that the rate of adverse events using the Air-Q supra-glottic device are comparable to other devices such as LMA.
- Trial with medical device
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Air-Q Intubation Laryngeal Mask | Experimental | Device: Air-Q Intubation Laryngeal MaskPatients will be intubated using the Air-Q Intubation Laryngeal Mask and subsequently intubated with a commercially available endotracheal tube via the Intubation Laryngeal Mask. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- elective surgery requiring tracheal intubation using an oral tracheal tube
- anticipated extubation in the operating room
- American Society of Anaesthesiologist Physical Status 1-3
- age = 18 years and = 85 years
- oral and written informed consent
Key exclusion criteria (8 listed)
- pharyngeal, laryngeal or tracheal pathology, including tracheostomy
- mouth opening < 2.5 cm
- any form of airway infection such as upper-respiratory tract infection, pneumonia or suspected tuberculosis
- any disease that might impair the power of judgement (psychiatric disease, dementia)
- indicated rapid sequence induction which is a standard when high risk for regurgitation and/or aspiration is present
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 |
|---|---|---|
| Air-Q Intubation Laryngeal MaskPatients will be intubated using the Air-Q Laryngeal Mask. | Device | Air-Q Intubation Laryngeal Mask |
Primary outcome
Success rate of blind intubation via the disposable Air-Q self-inflating laryngeal intubation mask.
Time frame: 300 seconds
Success is defined as placement of a tracheal tube into trachea with no more than two insertion attempts.
16 secondary outcomes
Time for insertion of the Air-Q laryngeal mask
Time frame: 300 seconds
Time for insertion of the tube
Time frame: 300 seconds
First attempt rate and second attempt rate
Time frame: 300 seconds
Time for removal of the Air-Q ILA device after successful intubation
Time frame: 500 seconds
Rate of misplacement of the ILA
Time frame: 300 seconds
Rate of misplacement of the tube
Time frame: 500 seconds
risk factors of insertion failures
Time frame: 500 seconds
Rate of airway injuries
Time frame: 5 hours
Tightness during leak test before relaxation
Time frame: 300 seconds
Tightness during leak test after relaxation
Time frame: 300 seconds
Maximum drop of saturation during airway management
Time frame: 500 seconds
Rate of adverse events
Time frame: 5 hours
Rate of necessity of alternative airway device
Time frame: 500 seconds
Rate of blood stained devices after removal of the ILA
Time frame: 500 seconds
Postoperative coughing after 2 hours and the next morning
Time frame: 24 hours
Postoperative hoarseness after 2 hours and the next morning
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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.
Donat R. Spahn, Prof MD principal investigator
University Hospital Zurich, Institute of Anaesthesiology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Air-Q Intubation Laryngeal Mask in people with Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube, run by University of Zurich at 3 sites in 2 countries.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 29 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of blind intubation via the disposable Air-Q self-inflating laryngeal intubation mask. (time frame: 300 seconds). 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 29 Jun 2016.