Clinical trial NCT01906060: Blind Intubation Through The Self-Pressurised Disposable Air-Q Laryngeal Intubation Mask: An International Multicentre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Success rate of blind intubation via the disposable Air-Q self-inflating laryngeal intubation mask.
timeFrame: 300 seconds
Secondary outcomes:
measure: Time for insertion of the Air-Q laryngeal mask
timeFrame: 300 seconds
measure: Time for insertion of the tube
timeFrame: 300 seconds
measure: First attempt rate and second attempt rate
timeFrame: 300 seconds
measure: Time for removal of the Air-Q ILA device after successful intubation
timeFrame: 500 seconds
measure: Rate of misplacement of the ILA
timeFrame: 300 seconds
measure: Rate of misplacement of the tube
timeFrame: 500 seconds
measure: risk factors of insertion failures
timeFrame: 500 seconds
measure: Rate of airway injuries
timeFrame: 5 hours
measure: Tightness during leak test before relaxation
timeFrame: 300 seconds
measure: Tightness during leak test after relaxation
timeFrame: 300 seconds
measure: Maximum drop of saturation during airway management
timeFrame: 500 seconds
measure: Rate of adverse events
timeFrame: 5 hours
measure: Rate of necessity of alternative airway device
timeFrame: 500 seconds
measure: Rate of blood stained devices after removal of the ILA
timeFrame: 500 seconds
measure: Postoperative coughing after 2 hours and the next morning
timeFrame: 24 hours
measure: Postoperative hoarseness after 2 hours and the next morning
timeFrame: 24 hours
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Medical University Lodz
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institute of Anaesthesiology
state: ZH
city: Winterthur
country: Switzerland
facility: KantonsSpital Winterthur
Study officials:
affiliation: University Hospital Zurich, Institute of Anaesthesiology
name: Donat R. Spahn, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: