Air Q Laryngeal Airway Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation

Difficult Intubation Clinical Trial

Official title:

Air Q Intubating Laryngeal Airway (Air QILA) Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation Assisted by Tube Exchanger, a Randomized Comparative Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05607433
• Other study ID #: supraglottic devices
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: December 2022

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: Hoda Alrify
• Phone: 002 01004226722
• Email: hodazakariasaleh[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to compare the efficacy of the Ambu AuraGain to that of the Air Q ILA as a conduit for endotracheal intubation assisted by tube exchanger. The comparison will be in terms of total intubation time, success rate of insertion of the tube exchanger as well as endotracheal intubation and complications.

Description:

Very few studies discussed assisted endotrachealc intubation using certain tools as bougie through the Air Q ILA . the hypothesis in this study is that the use of flexible, small calibre tube exchanger introduced through both supraglottic devices into the trachea as guidance for endotracheal intubation, will have shorter intubation time with the Ambu AuraGain than the Air Q ILA and less complications in both devices.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age : 18 to 60
• ASA physical status 1 and 2
• body weight less than 90 kilos
• Ganzouri airway score less than or equal to 3.

Exclusion Criteria:

• Active respiratory or cardiac disease
• Any expected airway difficulties
• Craniofacial abnormalities or fractures
• patients with abnormal coagulation profile

Related Conditions & MeSH terms

• Difficult Intubation

Intervention

Device:
• cook ®Airway Exchanger Catheter
A tube exchanger is a small calibre , flexible tube used to guide endotracheal intubation through a supraglottic device.

Locations

Country	Name	City	State
Egypt	Kasr Alainy Hospital	Cairo	Elmanial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Bakker EJ, Valkenburg M, Galvin EM. Pilot study of the air-Q intubating laryngeal airway in clinical use. Anaesth Intensive Care. 2010 Mar;38(2):346-8. — View Citation

Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach™) and the Air-Q™. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	postoperative hoarseness of voice	change of voice	2 hours postoperative
Primary	Total endotracheal intubation time	tube exchanger intubation time plus endotracheal intubation time	time of tube exchanger insertion and endotracheal tube insertion
Secondary	success rate of endotracheal intubation	incidence of successful endotracheal intubation	1 second after insertion tube exchanger until successful endotracheal intubation
Secondary	Tube exchanger insertion time	time from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea	from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea