Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-21 @ 11:35 PM
Study NCT ID:
NCT01906060
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2013-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blind Intubation Through The Self-Pressurised Disposable Air-Q Laryngeal Intubation Mask: An International Multicentre Trial
Sponsor:
University of Zurich
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: