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Safety and Efficacy Assessment of a New Tracheal Intubation Device Cleverscope. Success Rate of Cleverscope in Patients With Suspected Difficult Airway.
Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.
the investigators develope two part study. part I: the investigators collect data of 50 patients prospectively programed for general anesthesia and tracheal intubation without predictors of difficult airways. this patients were intubated with cleverscope, the investigators register best cormack-lehane (glottic vision) obtained with Cleverscope and best cormack obtained with direct laryngoscopy. the investigators register intubation succes rate and any complications during its use and after extubation. part II: after confirm safety and efficacy in patients without difficult airways (part I) the investigators use Cleverscope for the same pourpose on difficult airways patients. collecting same data . the investigators compare cormack-lehane in this patients with Cleverscope and commercial Videolaryngoscope C-MAC.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Lucas Rovira
La Pobla de Vallbona, Valencia, Spain
Start Date
October 1, 2019
Primary Completion Date
October 1, 2023
Completion Date
December 1, 2023
Last Updated
May 16, 2022
134
ESTIMATED participants
Cleverscope
DEVICE
Laryngoscope / Videolaryngoscope C-MAC® Storz
DEVICE
Lead Sponsor
Hospital General Universitario de Valencia
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06091631