Intubation; Difficult Clinical Trial
Official title:
Comparison of iLTS-D® and ILMA® for Intubation With Fiberoptic Control. Multicentric Randomised Patient-blind Study of Non-inferiority
The primary purpose of this study is to compare with a non-inferiority randomised study the new laryngeal tube (Intubating Laryngeal Tube Single-Disposable - iLTS-D) to the well-established Intubating Larygeal Mask Airway (ILMA/ Fastrach) for the success rate and time for intubation under fiberoptic control. Secondary purposes are success rates and times for ventilation for both devices and finally success rate of gastric tube placement.
Status | Recruiting |
Enrollment | 198 |
Est. completion date | September 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Informed Consent as documented by signature (Appendix Informed Consent Form) - Adult patients who will undergo an elective surgery under general anesthesia requiring tracheal intubation - American Society of Anesthesiology ASA Risk Class 1-3 Exclusion Criteria: - Known difficult intubation - Previous surgery of Ear Nose Throat (ENT) - Symptomatic gastrooesophageal reflux - Nauseas at time of operation - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, - Previous enrolment into the current study, - Enrolment of the investigator, his/her family members, employees and other dependent persons |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dpt of Anesthesiology, University of Lausanne CHUV | Lausanne | VD |
Lead Sponsor | Collaborator |
---|---|
Patrick Schoettker,MD PD |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | success rate intubation | The primary endpoint will be the success rate for tracheal intubation under fiberoptic control through both devices. Intubation for patients with difficult airways is the main feature of those devices. | 60 minutes | |
Primary | time necessary to intubate | We will measure the time necessary to intubate | 180 seconds | |
Secondary | success rate ventilation | Secondary endpoint will be success rate for ventilation for both devices | 60 minutes | |
Secondary | time to ventilation | Secondary endpoint will be time necessary to achieve for ventilation for both devices | 180 seconds | |
Secondary | time to intubation | Secondary endpoint will be time necessary for intubation for both devices | 180 seconds |
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