Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube Clinical Trial
| Verified date | June 2016 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Poland | Medical University Lodz | Lodz | |
| Switzerland | KantonsSpital Winterthur | Winterthur | |
| Switzerland | University Hospital Zurich, Institute of Anaesthesiology | Zurich | ZH |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Poland, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 300 seconds | Yes |
| Secondary | 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 | 300 seconds | No |
| Secondary | 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 | 300 seconds | No |
| Secondary | First attempt rate and second attempt rate | 300 seconds | No | |
| Secondary | Time for removal of the Air-Q ILA device after successful intubation | 500 seconds | No | |
| Secondary | Rate of misplacement of the ILA | 300 seconds | Yes | |
| Secondary | Rate of misplacement of the tube | 500 seconds | Yes | |
| Secondary | risk factors of insertion failures | 500 seconds | Yes | |
| Secondary | Rate of airway injuries | 5 hours | No | |
| Secondary | Tightness during leak test before relaxation | 300 seconds | No | |
| Secondary | Tightness during leak test after relaxation | 300 seconds | No | |
| Secondary | Maximum drop of saturation during airway management | 500 seconds | Yes | |
| Secondary | 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 | 5 hours | Yes |
| Secondary | Rate of necessity of alternative airway device | 500 seconds | No | |
| Secondary | Rate of blood stained devices after removal of the ILA | 500 seconds | No | |
| Secondary | Postoperative coughing after 2 hours and the next morning | 24 hours | No | |
| Secondary | Postoperative hoarseness after 2 hours and the next morning | 24 hours | No |