Status:
COMPLETED
Blind Intubation Through The Self-Pressurised Disposable Air-Q Laryngeal Intubation Mask: An International Multicentre Trial
Lead Sponsor:
University of Zurich
Conditions:
Elective Surgery Requiring Tracheal Intubation Using an Oral Tracheal Tube
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT01906060
Start Date
July 1 2013
End Date
June 1 2016
Last Update
June 29 2016
Active Locations (3)
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1
Medical University Lodz
Lodz, Poland, 90-419
2
University Hospital Zurich, Institute of Anaesthesiology
Zurich, Canton of Zurich, Switzerland, 8091
3
KantonsSpital Winterthur
Winterthur, Switzerland, 8401