NCT03902704

Safety and Efficacy of Cleverscope. A New Medical Device for Tracheal Intubation

Safety and Efficacy Assessment of a New Tracheal Intubation Device Cleverscope. Success Rate of Cleverscope in Patients With Suspected Difficult Airway.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Hospital General Universitario de Valencia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cleverscope is a new medical device that transform a laryngoscope into a videolaryngoscope. previous its commercialization we evaluate its safety and efficacy.

Detailed description

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.

Conditions

• Anesthesia Intubation Complication
• Difficult Intubation

Interventions

Type	Name	Description
DEVICE	Cleverscope	the device is used in patients without difficult airways predictors
DEVICE	Laryngoscope / Videolaryngoscope C-MAC® Storz	the device is used in patients with difficult airways predictors

Timeline

• Start date: 2019-10-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2019-04-04
• Last updated: 2022-05-16

Locations

1 site across 1 country: Spain