Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube
Conditions
Brief 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. 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
Interventions
DEVICEAir-Q Intubation Laryngeal Mask
Patients will be intubated using the Air-Q Laryngeal Mask.
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of blind intubation via the disposable Air-Q self-inflating laryngeal intubation mask. | 300 seconds | Success is defined as placement of a tracheal tube into trachea with no more than two insertion attempts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for insertion of the tube | 300 seconds | defined as the time beginning at the moment of insertion of the tube through the laryngeal mask until the appearance of the capnography waveform |
| First attempt rate and second attempt rate | 300 seconds | — |
| Time for removal of the Air-Q ILA device after successful intubation | 500 seconds | — |
| Rate of misplacement of the ILA | 300 seconds | — |
| Rate of misplacement of the tube | 500 seconds | — |
| risk factors of insertion failures | 500 seconds | — |
| Rate of airway injuries | 5 hours | — |
| Time for insertion of the Air-Q laryngeal mask | 300 seconds | defined as time beginning at the moment the ILA enters the mouth until the appearance of the capnography waveform |
| Tightness during leak test after relaxation | 300 seconds | — |
| Maximum drop of saturation during airway management | 500 seconds | — |
| Rate of adverse events | 5 hours | 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 |
| Rate of necessity of alternative airway device | 500 seconds | — |
| Rate of blood stained devices after removal of the ILA | 500 seconds | — |
| Postoperative coughing after 2 hours and the next morning | 24 hours | — |
| Postoperative hoarseness after 2 hours and the next morning | 24 hours | — |
| Tightness during leak test before relaxation | 300 seconds | — |
Countries
Poland, Switzerland
Outcome results
None listed